MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751PNAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751PNAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the insulin pump alarmed motion sensor test failure.The customer¿s blood glucose level was unknown.Customer stated that pump was dr has rewound the pump several times and is getting the same motor error.The customer was assisted with troubleshoot and customer reports that an alarm received was pump and cannot rewind.Assisted in performing a displacement test and test was failed.Customer stated pump cannot rewind and only displays motion sensor test failure.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the rewind, basic occlusion, prime/compromised force sensor system and displacement test.Insulin pump was received with stuck motor error alarm loop during bolus delivery.Unable to verify motion sensor test failure alarm due to motor error alarm.The motor was tested outside of the device and passed.Insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, stained end cap sticker, stained address/serial number label and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-751PNAP
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 6999634
• Report Number: 2032227-2017-63682
• Device Sequence Number: 13895587
• Product Code: OZO
• UDI-Device Identifier: 00643169507340
• UDI-Public: (01)00643169507340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751PNAP
• Device Catalogue Number: MMT-751PNAP
• Device Lot Number: A3751PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR