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

Model Number	MMT-751PNAH
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose and they did not receive a low battery alert prior to off no power alert.The customer blood glucose level was 530 mg/dl at the time of incident.The customer stated the battery was not previously used.Customer reported the insulin pump was not dropped.Customer stated the battery cap was not loose, cracked or damaged.This was the second occurrence of off no power alert now without a low battery warning.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device power up properly after battery installation.No blank display noted.Device was received with normal operating currents and passed self-test, a21 error test and displacement test.No unexpected off no power, bad battery, low battery, battery out limit or failed battery test alarms noted during testing.

• Brand Name: 530G INSULIN PUMP MMT-751PNAH
• 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: 9641045
• Report Number: 3004209178-2020-61435
• Device Sequence Number: 11307589
• Product Code: OZO
• UDI-Device Identifier: 00643169507326
• UDI-Public: (01)00643169507326
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751PNAH
• Device Catalogue Number: MMT-751PNAH
• Device Lot Number: A3751PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 164