BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2905067 · Received January 9, 2013

    Report

    Report Number
    2032227-2013-00075
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK. UNABLE TO VERIFY THE MOTOR ERROR ALARM DUE TO THE LOOSE DRIVE SUPPORT DISK. ALSO, THE INSULIN PUMP HAD NOISE MOTOR DUE TO A FAULTY MOTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ALARM DURING THE MANUAL PRIME. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM. 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
    12692 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR