Complaint documentation
For this complaint code, please obtain the following:
- RGA (Return Goods Authorization)
Problem
Failure to deploy sensor from the applicator
Questions to be asked
N/A
Questions to be documented
214.1 Which step was difficult in deploying the sensor/wearable?
214.2 Did the applicator release the sensor/wearable?
214.3 G6 only: was the needle exposed when the applicator was removed?
214.4 Was the Applicator dropped?
Actions
- Record answer.
• Needle retraction
• Did not deploy
• Did not detach from applicator
• Bent sensor wire during insertion
• Bent sensor wire after removal (RGA not required) - Record answer.
a. G6 / D1 : If sensor is still stuck to patient, have patient gently pull applicator up until adhesive is visible. Grab and peel the edge of the patch. While holding the adhesive patch, gently rock back the applicator away from the body.
b. G7 / D1+ : If needle is partially in patient’s skin: Advise they pull the applicator perpendicular to the skin’s surface. If needle is no longer in the patient’s skin but the sharps protection mechanism did not engage (the needle is still accessible to the user): Advise the user to put the cap back on and to unblock the applicator and finish the deployment cycle. - Record answer.
- Record answer.
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