BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 445615 · Received February 25, 2003

    Report

    Report Number
    MW1027665
    Event Type
    Other
    Date Received
    February 25, 2003
    Date of Event
    February 23, 2003
    Report Date
    February 25, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2002 PT RECEIVED PARADIGM INSULIN PUMP, PT NOW WAITING FOR 3RD INSULIN PUMP TO BE SENT TO THEM, AS A RESULT OF PUMP MALFUNCITON. DURING THESE MALFUNCTIONS, THEY HAVE EXPERIENCED EXTREMELY HIGH BLOOD SUGARS, KETONES, HEADACHES, WEAKNESS, AND POOR JUDGEMENT. IN REFERENCE #9, THE PRODUCT WILL BE RETURNED TO THE MFR WITHIN THE WEEK SO RPTR CAN GET A REPLACEMENT UNIT. RPTR'S FIRST MALFUNCTIONING PUMP WAS DUE TO THE "SOFTWARE GOING BAD." THE SECOND MALFUNCTION WAS DUE TO THE DRIVER ARM "GOING BAD", WHICH IS THE COMPONENT THAT PUSHES THE INSULIN THROUGH THE LINE. THE CO HIGHLY RECOMMENDED RPTR IMMEDIATELY DISCONNECT THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM/MINIMED 511 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other