MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAS
Medical Device Problem Codes	Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
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's mother reported via phone call that the insulin pump received unexpected restart and a cold reset was performed alarm as well as button error alarm.The customer¿s blood glucose was unknown.Customer reported that they were unable to clear the alarm.Customer stated hits the escape button and rerouting to up button.Troubleshooting was performed.Customer stated that time was wrong.Customer was advised that the insulin pump needed to be replaced, to discontinue use of the insulin pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Device passed the displacement test, self test and a21 alarm test.No unexpected a21 alarm anomalies noted.No unexpected rerouting anomalies noted.Device received with broken belt clip slot, broken battery tube threads and broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 9388269
• Report Number: 2032227-2019-123969
• Device Sequence Number: 3040446
• Product Code: OYC
• UDI-Device Identifier: 00643169202344
• UDI-Public: (01)00643169202344
• Combination Product (Y/N): N
• 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): 02/19/2020

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: A8523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 63