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

Model Number	MMT-551NAH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/05/2018
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.The device has been returned, but not yet evaluated.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 a blank display.The customer¿s blood glucose level was over 300 mg/dl at the time of the incident.The customer was assisted with troubleshooting and customer reports display was blank currently.Customer states the display did not returned.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The customer was advised the insulin pump will be replaced as per troubleshoot.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump was received with blank display due to moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.Unable to perform operating currents, self-test, rewind test and displacement test due to blank display.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• 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: 7661903
• Report Number: 3004209178-2018-87754
• Device Sequence Number: 2629289
• Product Code: OZO
• UDI-Device Identifier: 00643169736023
• UDI-Public: (01)00643169736023
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/14/2018

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: Other
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A6551NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: 60 YR
• Patient Weight: 153