BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3231223 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02964
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AND SQUIRTED INSULIN DURING THE MANUAL PRIME. INSPECTED THE DRIVE SUPPORT CAP, AND IT DID NOT APPEAR TO BE DAMAGED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331458 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1