MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Visual Prompts will not Clear (2281); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
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
It was reported that the insulin pump all the buttons were not responding and had frozen display.The customer¿s blood glucose level was unknown at the time of the incident.Customer stated insulin pump had unexpected restart alarm and they were unable to clear the alarm.Customer were unable to complete troubleshooting.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
No frozen screen or blank display noted.Device time/clock moved.Device had unresponsive all buttons due to moisture damage lcd board.Unable to perform operating currents, self-test, a21 error test and displacement test or verify a21 alarm due to unresponsive button.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 8919284
• Report Number: 2032227-2019-50566
• Device Sequence Number: 14071176
• Product Code: OYC
• UDI-Device Identifier: 00643169478534
• UDI-Public: (01)00643169478534
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: B3722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1