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

Model Number	MMT-751NAL
Medical Device Problem Codes	Premature Discharge of Battery (1057); No Display/Image (1183); Visual Prompts will not Clear (2281); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/11/2020
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 level was 400 mg/dl.Customer stated that insulin pump had unexpected restart.Customer stated that piston inside the insulin pump was stuck all the way up.Customer also stated that they were unable to clear the alarm.Customer was advised to observe time clock for one minute to verify if time advances and it was not advanced.Customer stated that screen was blank after inserting new battery.Customer stated that contacts on the battery cap was not missing or damaged.Customer stated that the display did not return.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
No frozen screen, blank display or button error alarm noted.Device time or clock moved.However, device had unresponsive esc and act buttons due to unlocked lcd keypad connector.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and displacement test or verify a21 alarm due to unresponsive button.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 9852836
• Report Number: 3004209178-2020-88603
• Device Sequence Number: 2921138
• Product Code: OZO
• UDI-Device Identifier: 00643169404328
• UDI-Public: (01)00643169404328
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/27/2020

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-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A3751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Weight: 95