Complaint documentation

For this complaint code, please obtain the following:

  • Data
  • RGA (Return Goods Authorization) 


Problem

Transmitter/Wearable not communicating with the display device.

Questions to be asked

N/A

Questions to be documented

215.1 Was the patient’s transmitter/wearable successfully paired prior to signal loss to Dexcom approved devices?
215.2 What device(s) is/are the user’s transmitter/wearable paired with?
215.3 How long did the Signal loss occur?
215.4 What time did the Signal Loss occur?
215.5 Was the Device more than 20 feet or 6-meters away from the transmitter/wearable for more than 15mins?
          215.5.1 If yes, did the signal return after the affected devices were within range after 5mins?
215.6 Which device(s) are displaying the signal loss?.

Receiver Only:
215.7 Is the Bluetooth Icon blinking or solid?

Smart Device:
215.8 Is the patient using any other Bluetooth accessories at the time of signal loss?

Actions

  1. Record answer. If patient’s transmitter/wearable was not successfully paired prior to signal loss, change to classification code 113.
  2. Record answer.
  3. Record answer.
    If 215.3 indication <1 hr, or <15 min, RGA is not required.
  4. Record answer.
  5. Record answer. If patient was more than 20 feet or 6-meters away, have them move within 20 feet/6-meters of the transmitter/wearable and wait 5 minutes for the transmitter/wearable and display device to establish connection.
  6. Which devices are displaying signal loss?
    1. SMART DEVICE users or if transmitter/wearable is PAIRED TO BOTH display device and receiver but SIGNAL LOSS IS ONLY ON SMART DEVICE.
                   1. Ask user to open the mylife App on the phone and ask what they see?
                   2. If they have Signal Loss, ask them to keep the app open for at least 5 min.
                           1. If they are talking to you on the same phone, verify they are not using a Bluetooth headset or Bluetooth car system.
                   3. In the meantime, document all information.
                   4. After 5 min if Signal Loss is still displayed on app, proceed with additional troubleshooting.
                            1. If the app and transmitter/wearable reconnect, do not replace the transmitter/wearable. Educate user how the system works, the app and transmitter/wearable only communicate for a few seconds every 5 minutes, the user must wait at least 5 minutes and the app must always be left open. Document results from any troubleshooting steps.
                             2. The transmitter/wearable functions differently than other Bluetooth devices which constantly connect to accessories and when powered off and on, connect immediately. Constant connection drains battery life and because other Bluetooth accessories have rechargeable batteries, constant connection is made possible for them.
                    5. Samsung only phone user:
                            1. With OS version 11, Samsung has introduced a battery optimization feature which interferes with the mylife App and causes Signal Loss. Ensure this feature is turned off for the mylife App to function properly. Do not replace transmitter/wearable and assign the complaint to the Mobile App:
                                       1. Go to phone settings→Apps
                                       2. Click on the three vertical dot menu on the top right corner and select special access.
                                       3. Click on Optimize battery usage
                                       4. Select All from dropdown list
                                       5. Look for Dexcom G6 App and set to Off
                    6. Have user toggle Bluetooth and wait for at least 5 min for the phone and transmitter/wearable to reconnect. The user should not access any other apps on the phone while waiting for the transmitter/wearable to reconnect.
                            1. Phone and the transmitter/wearable must be within range and have a clear path of each other with nothing blocking during this time.
                            2. Ensure the user is not using any Bluetooth accessories during this time, such as headsets or car Bluetooth system.
                    7. If that does not work, ask the user to power cycle their device and once it’s powered back on open the mylife App and keep it open for at least 5 minutes without using any other apps at that time.
                             1. Phone and the transmitter/wearable must be within range and have a clear path to each other with nothing blocking during this time.
                    8. Remove paired device and re-pair transmitter/wearable

To manually forget a device paired via Bluetooth on Android:
1. Navigate to Settings > Connected devices > Connection preferences > Bluetooth.

2. Find the device you want to forget/unpair in the list of paired devices.
3. Tap the appropriate device name or the settings “gear icon”.
4. Tap Forget or Unpair.

To manually forget a device paired via Bluetooth on iOS/iPhone:
1. Navigate to Settings > Bluetooth
2. Find the device you want to forget/unpair in the list of paired devices.
3. Tap the “More Info” button.
4. Tap Forget this Device.


          2. RECEIVER users or if transmitter/wearable is PAIRED TO BOTH display device and receiver, but SIGNAL LOSS IS ONLY ON RECEIVER.
                     1. If patient still has connection issue after Signal Loss the receiver and transmitter/wearable did not connect again, Power cycle the receiver.

                     2. Ask the patient if they have another transmitter/wearable to try to pair. If pairing is successful, then transmitter/wearable is at fault.
                                    1. If a new transmitter/wearable cannot pair, then send back both receiver and transmitter/wearable.

       7. Record answer. If the receiver Bluetooth icon is blinking and the transmitter/wearable never paired, move to 113.


SYSTEM AWARENESS

  1. Signal Loss is designed to alert the user if the Dexcom system, display device and transmitter/wearable are not able to communicate and provide a glucose reading. This can occur if the user moves around with the transmitter/wearable inserted on the body in a sensor session and the display device is out of reach or blocked from communicating with the transmitter/wearable. If user has intermittent signal loss, it is because of natural causes, and this is how the system is designed to work to alert the user.
    In rare cases where the communication does not re-connect, further troubleshooting can be done to understand the issue. After pairing, the display device and transmitter/wearable communicate over Bluetooth only for a few seconds every 5 min, when the transmitter/wearable sends the EGV value.
    This is different from other Bluetooth accessories which are always transmitting (this method consumes more battery power and these accessories can be re-charged).
    If the display device and transmitter/wearable are further away from each other than 20 feet or 6 meters, the EGV value might not reach the display device and a signal loss will alert the user, this is how the system is designed to work. Enhance your system experience by always carrying the display device with you even inside your home, at work or school.
    Even if the display device and transmitter/wearable are close to each other, something can be blocking the communication. Maintain a clear path between the transmitter/wearable and the display device so they can communicate every 5 min. If something is blocking the display device from connecting with the transmitter/wearable, a signal loss alert will let you know. This is how the system is designed to work.
    Smart Device users only:
    The Dexcom system only operates if the Dexcom app is left open. If the app is closed, it will not communicate with the transmitter/wearable. If you open the app after it has been closed, a Signal Loss alert may appear. To reconnect the app with the transmitter/wearable, wait at least 5 min for the smart device to connect without accessing other apps during this time. In this case, the app shows the Signal Loss alert to inform the user it has not communicated with the transmitter/wearable while closed.
    • Before putting down the phone, locking the phone, or while the phone is not being used, ensure the app is NOT closed. Always leave the Dexcom app open.
    • If the app is accidentally closed, open the app, and wait a minimum of 5 min for it to reconnect with the transmitter/wearable. Do not access other apps during this time.
    If using Bluetooth accessories: Your phone will repeatedly search for all Bluetooth devices listed on your phone. The phone might be busy searching for other devices and miss the transmitter/wearable communication (transmitter/wearables only communicate a few seconds every 5 min). The phone can also be busy handling data and miss the communication with the transmitter/wearable when other apps are used over Bluetooth. For example, if you are watching video, playing music, listening to podcast etc., using Bluetooth accessories such as headsets, speaker or while connected to the car Bluetooth system.
    • If Signal Loss occurs while using Bluetooth accessories, reduce the list of Bluetooth devices that are not used frequently and unpair/forget devices from the phones list of Bluetooth devices.
    • Minimize other application usage over Bluetooth if you experience signal loss.
    Changing between smart devices, using multiple phones or devices such as tablet, iPad or iPod can cause communication issues. Always Unpair/forget the transmitter/wearable from a device before changing to another device. It might take over 20 min for the phone/transmitter/wearable to unpair.
    • If a transmitter/wearable was ever paired with a different phone, tablet, iPad, or iPod, that device might still connect with the transmitter/wearable without the user knowing and cause signal loss on the primary device.
    If user has bought a new phone or device, ensure the previous device is left powered off or unpair/forget the transmitter/wearable from the device Bluetooth menu. This to eliminate multiple devices connecting to the same transmitter/wearable causing signal loss on one of the devices.


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Reasons behind

N/A

Related issues

113 Pairing

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