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

Model Number	MMT-751PNAH
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Material Integrity Problem (2978); Moisture or Humidity Problem (2986); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
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 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
The customer reported via phone call that the buttons of insulin pump was hard to press.Customer¿s blood glucose level was unknown.The customer also reported that the insulin pump had two cracks around battery opening and small crack near reservoir opening.The customer also stated that they had rewind the insulin pump more than once per reservoir change.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display and constant tone due to moisture damage on the electronics assembly.Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test or verify button keypad anomaly, failed battery test alarm and unexpected error message anomaly due to blank display.Device received with moisture damage motor, vibrator and battery tube assembly.Device received with broken battery tube threads.Cracked reservoir tube lip and stripped battery cap coin slot.The p-cap locks into the reservoir compartment properly noted.

• Brand Name: 530G INSULIN PUMP MMT-751PNAH
• 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: 8535074
• Report Number: 3004209178-2019-85437
• Device Sequence Number: 14061109
• Product Code: OZO
• UDI-Device Identifier: 00643169507326
• UDI-Public: (01)00643169507326
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/14/2020

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-751PNAH
• Device Catalogue Number: MMT-751PNAH
• Device Lot Number: A3751PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 69