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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump received with blank display due to j1 battery connector broken noted.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a blank display.The customer stated they were not able to resolve the blank display issue.The customer reported that something was wrong with their pump and they had been having erratic blood glucose readings for 2 to 3 weeks.The customer reported getting a high on the day of the call.No harm requiring medical intervention was reported.Troubleshooting was completed but did not resolve the issue.The customer reported issues with replacement pump draining batteries faster than normal.The insulin pump will be returned for analysis.

• 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; * 00777-3869
• MDR Report Key: 11125713
• Report Number: 2032227-2021-101363
• Device Sequence Number: 14382590
• Product Code: OZO
• UDI-Device Identifier: 00643169736023
• UDI-Public: (01)00643169736023
• 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
• Report Date (Section B): 01/06/2021

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-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A6551NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 160