BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER DEX

    MDR report key: 500705 · Received November 25, 2003

    Report

    Report Number
    1810909-2003-00424
    Event Type
    Malfunction
    Date Received
    November 25, 2003
    Date of Event
    October 25, 2003
    Report Date
    November 24, 2003
    Manufacturer
    BAYER HEALTHCARE, LLC DIAGNOSTIC DIVISION
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE METER WAS DEAD. A REVIEW OF THE SYSTEM WAS CONDUCTED OVER THE PHONE. AFTER REMOVING AND REINSERTING THE BATTERIES THE SYSTEM WAS FUNCTIONAL, HOWEVER THE REVIEW OF THE SYSTEM INDICATED THAT SEGMENTS WERE MISSING FROM THE DISPLAY. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED. THE CUSTOMER WAS INVITED TO CALL 24/7 WITH FUTURE QUESTIONS/CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER DEX BLOOD GLUCOSE METER CFR BAYER HEALTHCARE, LLC DIAGNOSTIC DIVISION 3952 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN