BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 499334 · Received December 5, 2003

    Report

    Report Number
    2032227-2003-01334
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    June 27, 2003
    Report Date
    November 7, 2003
    Manufacturer
    MINIMED, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INDICATED THAT A RECEIVED NOTICE VIA MEDWATCH FORM WAS RECEIVED FROM THE FDA. THERE IS NO CUSTOMER INFO ON THE FORM OTHER THAN THE EVENT OR PROBLEM. IT WAS REPORTED THAT THE CUSTOMER WAS USING A MEDTRONIC MINIMED INSULIN PUMP. THE CUSTOMER WAS PRIMING THE PUMP FOR A NEW INSERTION SET. THE REPORT STATED THAT THE PUMP HAD PRIMED A LARGE AMOUNT OF INSULIN WHILE THE CUSTOMER WAS CONNECTED TO THE PUMP. NO FURTHER DETAILS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other