BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2970500 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91138
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    May 15, 2012
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST, AND THE DEVICE WAS RECEIVED WITH MOTOR ERROR ALARMS DURING REWIND AS A RESULT OF THE MOTOR ENCODER SIGNAL BEING OUT OF PHASE. UNABLE TO CONFIRM UNEXPECTED OFF NO POWER ALARM. THE INSULIN PUMP PASSED THE OPERATING CURRENTS.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ACCIDENTALLY SCANNED BY AN MRI MACHINE WHEN THE CUSTOMER WAS RUSHED TO THE HOSPITAL FOR AN UNRELATED EMERGENCY. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74471 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1