Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Pump received with blank display and constant tone due to moisture damage on the electronics assembly. Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test or verify prime/fill anomaly, rewind anomaly and excessive no delivery alarm due to blank display. Pump received with moisture damage motor, vibrator and battery tube assembly. Pump received with cracked battery tube threads. The p-cap locks into the reservoir compartment properly noted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
Information received by medtronic indicated that the insulin pump had a cracks in the battery area, no delivery alarm. Customer stated that it was louder during rewinding and priming. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5