Unit received with blank display due to corroded battery tube. Unable to perform operating currents, self-test, a21 error test and displacement test or verify low batt alarm due to blank display. Unit had stripped battery cap coin slot (p), cracked battery tube threads. Reservoir tube lip was inspected and no anomaly was noted. The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10
Information received by medtronic indicated that the insulin pump had a pump error alarm. The customer stated they were not able to clear the alarm and were not able to complete the rewind process. (details that led to the event and add relevant information if applicable). No harm requiring medical intervention was reported. The insulin pump was returned for analysis.
Patient Sequence No: 1, Text Type: D, B5