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

Model Number	MMT-751NAP
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was unknown.The customer reported that insulin pump was exposed to moisture.The customer was using an old insulin pump that she got the button error on.The customer was assisted with troubleshooting for fluid exposure.The customer reported that the buttons stopped working the next day and the screen went blank.The customer was advised to discontinue use of the insulin pump and to revert to the backup plan.The customer was advised the pump will be replaced as per troubleshoot.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
All buttons functioning properly.However, found slightly corroded keypad traces.No button error alarm during testing.Insulin pump passed displacement test, self test, off no power test and all operating currents tested within the spec range.Insulin pump was monitored and tested with no blank display noted.Insulin pump received with moisture damage on electronics assembly noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 8184178
• Report Number: 2032227-2018-77735
• Device Sequence Number: 2141953
• Product Code: OZO
• UDI-Device Identifier: 00643169736092
• UDI-Public: (01)00643169736092
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/08/2019

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-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A6751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 82