BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3171078 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02450
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT SHE WAS GETTING MULTIPLE MOTOR ERROR ALARMS DURING THE PRIME PROCESS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. TROUBLESHOOTING WAS PERFORMED, AND CONFIRMED MOTOR ERROR AND OTHER ERROR ALARMS IN THE ALARM HISTORY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270825 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR