BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143615 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94347
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE OPERATING CURRENTS. NO UNEXPECTED LOW BATTERY ALARMS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NO ANOMALY FOUND ON THE MOTOR SLIDE. NO REWIND ANOMALY NOTED. HOWEVER, THE INSULIN PUMP HAD A LOUD MOTOR NOISE DURING REWIND DUE TO FAULTY MOTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PISTON WAS MOVING UP AND DOWN, AND THE DEVICE WAS MAKING NOISE. THE CALLER ALSO MENTIONED THAT THE BATTERY DID NOT LAST LONGER. TROUBLESHOOTING WAS PERFORMED, AND THE SELF TEST PASSED. HOWEVER, THE DISPLACEMENT TEST FAILED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243877 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR