BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER DEX

    MDR report key: 496228 · Received November 5, 2003

    Report

    Report Number
    1810909-2003-00412
    Event Type
    Malfunction
    Date Received
    November 5, 2003
    Date of Event
    October 8, 2003
    Report Date
    November 4, 2003
    Manufacturer
    BAYER HEALTHCARE, LLC/DIAGNOSTIC DIVISION
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PORTIONS OF THE DIGITS ON DISPLAY ARE MISSING. A REVIEW OF THE SYSTEM WAS PERFORMED OVER THE PHONE. THE REVIEW INDICATED THAT SEGMENTS WERE MISSING FROM THE METER'S 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 3952H *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN