MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551NAB
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
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 they experienced high blood glucose.The customer's blood glucose was 467 mg/dl.The customer was treated with the manual injection.The insulin pump had compromised sensor system alarm.The troubleshooting was performed for the prime rewind.Customer stated that the drive support cap appeared normal.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However, device alarmed a33 during basic occlusion test due to loose or protruded drive support disk noted.Unable to perform prime/a33 test, occlusion test or excessive no delivery test due to a33 alarms.

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• 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: 10193435
• Report Number: 2032227-2020-136367
• Device Sequence Number: 11587738
• Product Code: OZO
• UDI-Device Identifier: 00643169503625
• UDI-Public: (01)00643169503625
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2020

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-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A4551NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 120