BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4223073 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47407
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED 7.2 UNIT BOLUS AND OCCLUSION TEST AND MONITORED IN 50C OVEN FOR 24 HRS AND NO EXCESSIVE "NO DELIVERY" ALARM NOTED. UNIT HAD E-01 ALARM DUE TO LEAKY C1 ON MB. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A NO DELIVERY ALARM AND AN ADDITIONAL ERROR ALARM. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705505 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR