Complaint documentation

For this complaint code, please obtain the following:

  • Data


Problem

Patient’s display device displays that the application is unable to calibrate or is prompting for calibrations unexpectedly.

Questions to be asked

N/A

Questions to be documented

216.1 What calibration message appeared?
216.2 What display device is showing the calibration message? (App, Receiver, Insulin Pump)
216.3 Has the patient previously calibrated this sensor?
216.4 Was the calibration value entered on two displays?
216.5 Was the calibration entered according to the IFU?
216.6 Did the patient take medication containing acetaminophen (paracetamol) (I.e., Tylenol, Nyquil, Dayquil, etc.)?
       216.6.1 If yes, document the dosage and frequency.
216.7 Did the patient take Hydroxyurea?
       216.7.1 If yes, document the dosage and frequency.

Actions

1. Select from drop-down: Calibrate in 15 mins (readings stopped; Calibrate now (readings continued), Unable/Unwilling to answer
2. Select from drop-down: App; Receiver; Insulin Pump; Multiple devices
3. Record answer.
4. Record answer. Calibration only needs to be entered on one device.
5. Record answer.
6. Record answer.
                           1. Record the dosage, frequency, and time of last dose prior to the failure. G6/G7 is contraindicated for amounts over 1,000 mg over the course of 6 hours. Paracetamol can falsely elevate CGM readings. The length of time that acetaminophen (paracetamol) affects the system's performance is based on dose and length of time since dose.
7. Record answer.
                            1. Record all usage and frequency of drug, even if the dosage is small. (Note: The length of time that hydroxyurea affects the system's performance is based on dosage and length of time since last dose. Hydroxyurea is a medication used in sickle-cell disease and cancer treatment. It’s also known as “Hydroxycarbamide.”)

Images

Reasons behind

Related issues

Issues with same labels

There is no content with the specified labels

Back to overview