BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 464538 · Received June 3, 2003

    Report

    Report Number
    MW1028622
    Event Type
    Malfunction
    Date Received
    June 3, 2003
    Date of Event
    February 22, 2003
    Report Date
    June 3, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FAILURE OF THE SEALS OF THE RESEVOIR OF THE PT'S MINI MED MODEL 506 INSULIN PUMP CAUSED A LEAK AND SHORTING OUT OF THE PT'S PUMP. THIS ALONG WITH THEIR ONLY HAVING HUMALOG INSULIN CAUSED THE PT TO CHECK THEIR BLOOD GLUCOSE LEVELS EVERY 2-4 HOURS AND INJECT HUMALOG EVERY 4 HOURS UNTIL MONDAY MORNING UNTIL THEIR DOCTORS OFFICE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED 506 A10302479

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other