BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4223078 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47406
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    January 30, 2006
    Report Date
    January 30, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH E-01 ALARM DUE TO LEAKY C1 ON MB. UNIT HAD MISSING OVERLAY ON CASE.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED ASSISTANCE WITH THE BOLUS FUNCTION AND SETTING THE RESERVOIR VOLUME OF THE INSULIN PUMP. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705729 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR