BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2142569 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01497
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE LEAD SCREW TEST DUE TO A STUCK MOTOR ARMATURE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT AN ALARM AND A HIGH BLOOD GLUCOSE READING OF 298 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP ALARMED DURING THE PRIME TEST. THE INSULIN PUMP DID NOT PASS THE LEAD SCREW TEST. 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
    1 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LUB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR