BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984102 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91473
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 26, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST FOLLOWED BY A MOTOR ERROR ALARM DURING REWIND AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. UNABLE TO PERFORM THE FUNCTIONAL TEST DUE TO MOTOR ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 177MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS EXPOSED TO A HIGH MAGNETIC FIELD WHILE HAVING AN MRI. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT AND PASSED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88083 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR