BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110037 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01920
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 REPORTED A MOTOR ERROR ALARM DURING NORMAL USE. THE CUSTOMER STATED THAT SHE HAD AN MRI SCAN RECENTLY, AND THE INSULIN PUMP WAS IN THE SAME ROOM, BUT WASN'T BEING WORN DURING THE SCAN. TROUBLESHOOTING WAS NOT POSSIBLE AS THE INSULIN PUMP WOULD NOT REWIND. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. THE REPORTED BLOOD GLUCOSE READING WAS 137 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210422 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR