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

Model Number	MMT-751NAL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Battery Problem (2885); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the insulin pump screen harder to see.The customer stated they the insulin pump had crack on reservoir compartment, priming taking longer to completed and unexplained no delivery alarms.Customer reported that the battery was less then 7 days, button had to be pressed harder to work during priming and rainbow effect on the screen.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with cracked battery tube threads and cracked reservoir tube window corner noted.The test reservoir p-cap was able to lock in place.Lcd display window look normal no rainbow effect noted.All buttons functioning properly.No button error alarm during testing.No moisture or corroded keypad found.No flatted keypad.Connector was inspected and locked on lcd board.Device passed self test, off no power test and all operating currents tested within the specification.No charge or battery anomaly were noted.Device passed basic occlusion test unable to prime at 2.5 lbs during prime or a33 test due to faulty force sensor resistor.Unable to verify no delivery or occlusion alarm or perform excessive no delivery test and occlusion test due to prime anomaly.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 10118069
• Report Number: 2032227-2020-126274
• Device Sequence Number: 16682733
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/27/2020

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-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR