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

Model Number	MMT-523RNAB
Medical Device Problem Codes	Premature Discharge of Battery (1057); 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	06/16/2019
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
The customer reported via phone call that the non of the buttons of the insulin pump were responding.The customer's blood glucose value was 121 mg/dl at the time of the incident.The customer stated that they were stuck in the rain and the insulin pump got wet.The customer later changed the battery due to an alert and received an unexpected restart alarm but non of the buttons were responding.The customer was unable to perform troubleshooting as the buttons were not responding.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
No frozen screen noted.Time/clock moved.Device received with button error alarm and had unresponsive all buttons due to corroded keypad traces.Unable to perform operating currents, self-test, a21 error test, and displacement test or verify a21 alarm due to unresponsive button.No moisture damage on electronic assembly during visual inspection.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
• 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: 8721136
• Report Number: 2032227-2019-19570
• Device Sequence Number: 11267948
• Product Code: OYC
• UDI-Device Identifier: 00643169221512
• UDI-Public: (01)00643169221512
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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-523RNAB
• Device Catalogue Number: MMT-523RNAB
• Device Lot Number: A000207242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/16/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 61