BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3033243 · Received April 3, 2013

    Report

    Report Number
    2032227-2013-01248
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AND ALARM AND INSULIN SHOOTING 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
    135983 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR