BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192662 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02597
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST, AND WAS UNABLE TO PRIME DUE TO A LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE, BATTERY TUBE THREADS AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME. 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
    294177 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR