BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 351594 · Received September 12, 2001

    Report

    Report Number
    2032227-2001-00080
    Event Type
    Malfunction
    Date Received
    September 12, 2001
    Date of Event
    August 17, 2001
    Report Date
    August 17, 2001
    Manufacturer
    MINIMED, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MMI SALES REP CALLED TO REPORT THE CUSTOMER WAS ADMITTED IN THE HOSPITAL FOR DKA. CUSTOMER'S DOCTOR CONTACTED MMI SALES REP AND REQUESTED A REPLACEMENT. ALSO STATED THAT CUSTOMER DROPPED THE PUMP A FEW WEEKS AGO. CUSTOMER WAS IN ICU AND THE HOSPITAL STAFF DID NOT HAVE TIME TO TROUBLESHOOT THE PUMP. MMI SALES REP DID NOT HAVE ANY ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41771 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED, INC. MMT-507CRUC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization