BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 376634 · Received February 11, 2002

    Report

    Report Number
    2032227-2002-00034
    Event Type
    Malfunction
    Date Received
    February 11, 2002
    Date of Event
    December 22, 2001
    Report Date
    December 22, 2001
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY MEMBER CALLED TO REPORT CUSTOMER WAS IN DIABETIC KETOACIDOSIS, BUT WAS NOT HOSPITALIZED. THE HIGH BLOOD GLUCOSE'S WERE SELF-TREATED WITH A MANUAL INJECTION. IT WAS NOTED THAT THE CANNULA WAS BENT IN THE PAST. IT WAS ALSO STATED THAT THE LEAD SCREW DID NOT APPEAR TO BE TURNING NOR DID THE INSULIN APPEAR TO BE EXITING. TROUBLESHOOTING WAS PERFORMED. THE TROUBLESHOOTING RESULTED IN A PUMP PREVENTING INSULIN FROM EXITING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR