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

Model Number	MMT-751LNAL
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/06/2020
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
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 459 mg/dl at the time of incident.Customer reported that the insulin pump had a blank display.Customer stated that they put a new battery but after that insulin pump would not turn on.The customer was assisted with troubleshooting.Customer stated the display was not blank less than 30 seconds and did not return.Customer stated display was blank currently.Customer remove the battery and inserted battery alarm did not display on the insulin pump screen.Customer stated the contacts on the battery cap were neither missing nor damaged.Customer stated battery compartment was neither damaged nor corroded.Customer stated the spring was neither damaged nor corroded.Customer stated display did not return after insulin pump restart.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device monitored for several days and no blank display noted.Device received with normal operating current.Device passed displacement test and self test.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• 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: 10395118
• Report Number: 2032227-2020-161644
• Device Sequence Number: 2705550
• Product Code: OZO
• UDI-Device Identifier: 00643169507760
• UDI-Public: (01)00643169507760
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/19/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Device Lot Number: A4751LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: 56 YR
• Patient Weight: 98