BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN PUMP 522

    MDR report key: 1100523 · Received August 5, 2008

    Report

    Report Number
    MW5007887
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    April 22, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBLEMS: INADEQUATE TRAINING AND SUPPORT. INCORRECT INFORMATION FROM HELPLINE. INCORRECT/INSUFFICIENT DOCUMENTATION. SEE ATTACHED LETTER TO MEDTRONIC FOR FURTHER DETAILS. RESULTING EVENTS: BLOOD SUGAR LEVELS FROM 40'S TO 400. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP 522 INSULIN PUMP LZG MEDTRONIC MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other