BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981770 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06044
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. THE DEVICE WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED FAILED BATTERY TEST ALARM OR BLANK DISPLAY ANOMALY OBSERVED. NO DAMAGE FOUND ON THE LCD ISOLATION TAPE NOTED. NO UNEXPECTED BATTERY ICON ANOMALY FOUND. THE UNIT WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, AND MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND REPORTED THAT THERE WAS A MOTOR ERROR ALARM. THERE WERE NO SIGNIFICANT EVENTS THAT LED TO THE ALARM. THE BLOOD GLUCOSE READING WAS NOT GIVEN. THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. IN TROUBLESHOOTING, THE UNIT DID REWIND. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458331 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR