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

Model Number	MMT-751PNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
It was reported by the customer that the insulin pump is making a high pitched noise, has a low battery alert and none of the buttons are responding.The time advances on the insulin pump.Troubleshooting was performed on the insulin pump for the low battery and the battery lasted more than one week.The customer woke up to a blood glucose of 56 mg/dl and the insulin pump alarming threshold suspend.The customer declined troubleshooting for the threshold suspend and will be returning the pump.The current blood glucose is 85 mg/dl.
Additional Manufacturer Narrative
All buttons function properly.No blocked keypad noted.No damage noted on keypad traces.The keypad connector on lcd board was locked.Unit was received with normal operating currents and no unexpected low battery, battery out limit and failed battery test alarms or audio/beep anomaly noted during testing.Unit passed self-test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Unit auto off alarm function properly and no anomaly noted.Unit had minor scratched lcd window, cracked lcd window, cracked case at display window corners, cracked battery tube threads and cracked reservoir tube lip.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: 530G INSULIN PUMP MMT-751PNAB
• 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: 6660828
• Report Number: 2032227-2017-22797
• Device Sequence Number: 1882685
• Product Code: OZO
• UDI-Device Identifier: 00643169507319
• UDI-Public: (01)00643169507319
• 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): 07/31/2017

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-751PNAB
• Device Catalogue Number: MMT-751PNAB
• Device Lot Number: A3751PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/28/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 165