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

Model Number	MMT-751RNAP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
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.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
The customer reported via phone call that they had a display anomaly.The insulin pump¿s screen was black.They had changed the battery with 3 brand new ones.The screen came up and they had received an unexpected restart alarm.They did a reset on the insulin pump but then the screen went black.The customer stated the display anomaly had been happening for 3 months.Troubleshooting was performed but the black screen did not disappear.The insulin pump passed the self-test.The unexpected restart alarm was resolved with a new battery.The customer¿s blood glucose level was unknown.Due to the black screen, the device will be replaced and returned for analysis.
Additional Manufacturer Narrative
The insulin pump was received with low battery life due to voltage leak on interface board.The insulin pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test, unexpected restart error test and off no power test.The insulin pump was tested with no missing segments/partial display, unexpected restart alarm and black display noted.The insulin pump was received with cracked reservoir tube lip, cracked case near display window corners and minor scratches on display window noted.

• Brand Name: 530G INSULIN PUMP MMT-751RNAP
• 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: 6708624
• Report Number: 2032227-2017-27974
• Device Sequence Number: 531918
• Product Code: OZO
• UDI-Device Identifier: 00643169507999
• UDI-Public: (01)00643169507999
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/05/2017

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-751RNAP
• Device Catalogue Number: MMT-751RNAP
• Device Lot Number: A3751RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 06/17/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 225