BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2873046 · Received December 13, 2012

    Report

    Report Number
    2032227-2012-08045
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK. ALSO, THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS STUCK IN A PRIMING LOOP, AND WAS NOT RECOGNIZING THE RESERVOIR. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC MINIMED MMT-512NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR