MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAB
Medical Device Problem Codes	Premature Discharge of Battery (1057); 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	07/13/2019
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.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 unexpected restart and a cold reset was performed and the buttons were not working.Customer¿s blood glucose level was 104 mg/dl at the time of incident.Customer reported that she was not able to clear the alarm.Customer also reported that the insulin pump was exposed to water.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump 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 and excessive no delivery test or verify a21 alarm and button keypad anomaly due to blank display.Insulin pump received with moisture damage motor, vibrator and battery tube assembly.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• 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: 8820685
• Report Number: 2032227-2019-35011
• Device Sequence Number: 3205934
• Product Code: OYC
• UDI-Device Identifier: 00613994743893
• UDI-Public: (01)00613994743893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/22/2019

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-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: A3723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 84