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

Model Number	MMT-751LNAS
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit alarmed motor error during rewind due to corrode the motor home switch.Unable to perform unable to perform operating currents, unexpected restart error test, self-test, rewind test, basic occlusion test, occlusion test, prime, compromised forced sensor system test, excessive no delivery test and displacement test or verify low battery alarm, cal error alarm or communicate to sensor simulator or bg meter due to motor error alarm.(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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that insulin pump had battery life was now quicker and rewinding now was much rougher than before.No harm requiring medical intervention was reported.The customer routinely got a calibration error, and at times unable to download into care link.The device will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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: 10675730
• Report Number: 2032227-2020-190322
• Device Sequence Number: 11513131
• Product Code: OZO
• UDI-Device Identifier: 00643169933224
• UDI-Public: (01)00643169933224
• 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
• Report Date (Section B): 10/13/2020

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-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A5751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR