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

Model Number	MMT-523RNAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2019
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 insulin pump had motor error.The customer¿s blood glucose was unknown at the time of incident.The customer state that they were unable to clear the alarm and unable to rewind the insulin pump.Customer reports they are unable to describe the possible damage to the drive support cap.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion test, self test and unexpected restart error test.The stop (idle) current and run current measurement tests are within specification.Device also passed off no power alarm test and the delivery accuracy test at 0.08765 inches.No unexpected low battery alarm or off no power alarm noted during testing.Drive support disk was inspected and no anomaly was noted.The test battery was removed and reinserted with no unexpected failed battery test alarm/bad battery alarm noted.Device was monitored for 2 days.No blank display, unexpected low battery alarm or unexpected off no power alarm noted during testing.Device was unable to prime during prime test due to faulty force sensor resistor (gold).Unable to perform the occlusion test and excessive no delivery test due to prime anomaly.No drive/motor anomaly, motor error alarm or e70 alarm noted during testing.The motor functions properly during testing.The motor was tested outside of the device and passed.Device had minor scratched display window, small, cracks on the battery tube threads, cracked reservoir tube and a scratched reservoir tube window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• 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: 8402717
• Report Number: 2032227-2019-02072
• Device Sequence Number: 16210438
• Product Code: OYC
• UDI-Device Identifier: 00643169221536
• UDI-Public: (01)00643169221536
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 03/28/2019

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A000290552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/03/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR