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

Model Number	MMT-551LNAP
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported via phone call that the insulin pump had unexpected restart alarm.The customer¿s blood glucose level was 285 mg/dl at the time of incident.The customer reported that they had unexpected restart alarm and was able to complete rewind.It was reported that the troubleshooting was performed and received another unexpected restart alarm after a battery change.The customer was advised to discontinue use of the pump and revert to backup plan per health care professional instructions.The customer was advised the pump will need to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to verify unexpected restart alarm and perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to blank display.

• Brand Name: 530G INSULIN PUMP MMT-551LNAP
• 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: 8398068
• Report Number: 3004209178-2019-63936
• Device Sequence Number: 13947076
• Product Code: OZO
• UDI-Device Identifier: 00643169933026
• UDI-Public: (01)00643169933026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/14/2019

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-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A5551LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 51