BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 530686 · Received March 4, 2004

    Report

    Report Number
    2032227-2004-00364
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    January 22, 2004
    Report Date
    February 5, 2004
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN REGARDING UNEXPLAINED HBG'S. THE PROGRAMMING AND HISTORIES WERE ACCURATE. TROUBLESHOOTING WAS PERFORMED AND THE PUMP PASSED THE BOLUS TEST. AT THE TIME OF THE CALL, THE CUSTOMER DID NOT HAVE A CLAMP AVAILABLE. A FEW HOURS LATER, THE CUSTOMER CALLED AND WANTED TO RUN THE OCCLUSION TEST. IT WAS INDICATED THAT THE CUSTOMER WAS UNABLE TO PRIME PROPERLY AND THAT INSULIN WAS EXITING DURING THE PRIME. THE CUSTOMER WAS ADVISED THAT A REPLACEMENT WILL BE SENT AND WAS EDUCATED ON THE TWO HBG RULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR