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

Model Number	MMT-551LNAB
Medical Device Problem Codes	Circuit Failure (1089); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with blank display, problem isolated to interface board.Unable to perform operating currents, self-test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test or verify pump error alarms due to blank display.
Event or Problem Description
The customer reported via phone call that the insulin pump had a watchdog time error and iop test failure.The customer's blood glucose level was unknown.The customer reported that they were able to clear the alarm and rewind the insulin pump.The customer reported that the insulin pump passed the self test.Customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to the backup plan.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAB
• 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: 8648534
• Report Number: 2032227-2019-08187
• Device Sequence Number: 19418188
• Product Code: OZO
• UDI-Device Identifier: 00643169932999
• UDI-Public: (01)00643169932999
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/28/2019

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-551LNAB
• Device Catalogue Number: MMT-551LNAB
• Device Lot Number: A5551LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR