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 Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump received with no (act, up and escape) button response due to moisture keypad traces.No button error alarm during testing noted.Unable to perform all functional testing including the displacement, operating currents, a21 error test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test due to buttons not responding.No moisture damage on the lcd board, mother board, interface board, rf board, motor, vibrator motor and battery tube assembly during visual inspection.
Event or Problem Description
Customer reported via phone call that insulin pump had pump exposed to fluid.Customer reported pump fell in the toilet.Customer reported that she was able to pick up the pump after it fell it only took a couple of seconds in the water insulin pump did not go blank and it did not alarm or vibrate or alert any pump error.Customer's blood glucose value was unknown at the time of the incident.The customer was assisted with troubleshooting.Customer will return device for analysis.

• 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: 8468654
• Report Number: 3004209178-2019-75070
• Device Sequence Number: 1664137
• 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
• Report Date (Section B): 04/01/2019

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-751PNAH
• Device Catalogue Number: MMT-751PNAH
• Device Lot Number: A3751PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/01/2019
• 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
• Patient Weight: 95