BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2930624 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-90604
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE SELF TEST. HOWEVER, THE DEVICE FAILED THE DISPLACEMENT TEST AS A RESULT OF THE MOTOR ENCODER SIGNAL BEING OUT OF PHASE. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD ALARMED MULTIPLE TIMES DURING NORMAL DEVICE USE. THE BLOOD GLUCOSE READING WAS 346MG/DL. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL DIFFERENT ERROR ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37998 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR