MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523KNH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523KNH
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Customer's mother reported via phone call that insulin pump had keypad anomaly and battery out limit.Customer¿s blood glucose was 138 mg/dl at the time of incident.The customer's current blood glucose level was 336 mg/dl.Troubleshooting was performed.The customer stated that they were not able to clear the alarm customer stated that numbers are ramping on their own.Customer stated the scroll bar is not moving with no input.The insulin pump was not exposed to a change in altitude.Advised the pump will need to be replaced.Advised to discontinue use of the pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with no (act, up and escape) button response due to corroded 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 or verify unexpected battery power loss anomaly due to buttons not responding.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523KNH
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9243533
• Report Number: 2032227-2019-109791
• Device Sequence Number: 16245580
• Product Code: OYC
• UDI-Device Identifier: 00613994743756
• UDI-Public: (01)00613994743756
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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-523KNH
• Device Catalogue Number: MMT-523KNH
• Device Lot Number: A000170189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 38