BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM

    MDR report key: 445872 · Received December 31, 2002

    Report

    Report Number
    MW4003447
    Event Type
    Malfunction
    Date Received
    December 31, 2002
    Date of Event
    December 28, 2002
    Report Date
    December 31, 2002
    Manufacturer
    MEDTRONIC MINIMED INC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2002 COMPLAINANT NOTICED THAT THE PUMP WAS NOT WORKING. THEY PUSHED THE "ESC" BUTTON, WITH NO RESPONSE. CONSUMER THEN TRIED TO PUSH THE OTHER BUTTONS AND REPLACING THE BATTERY, NOTHING HAPPENED. UPON CHECKING THEIR BLOOD SUGAR IT WAS HIGH AND THEY ADMINISTRATED INSULIN VIA A SYRINGE WHICH CORRECTED THE PROBLEM. CONSUMER CONTACTED THE FIRM AND WAS TOLD BY THE TECHNICIAN THAT WHEN THEY GET REPORTS OF A FROZEN SCREEN THERE ISN'T ANYTHING THEY CAN DO. THE TECHNICIAN SAID THAT HE WOULD SEND A REPLACEMENT UNIT. CONSUMER CONTACTED THEIR DOCTOR WHO INSTRUCTED THEM HOW TO LOWER THEIR SUGAR AND INSTRUCTED IF THEIR LEVEL DID NOT DECREASE TO CONTACT HIM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED INC * 041293-23

    Patients

    Seq Age Sex Outcome Treatment
    1 *