BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA DEX

    MDR report key: 490417 · Received October 7, 2003

    Report

    Report Number
    1810909-2003-00391
    Event Type
    Malfunction
    Date Received
    October 7, 2003
    Date of Event
    September 9, 2003
    Report Date
    October 7, 2003
    Manufacturer
    BAYER HEALTHCARE, LLC/DIAGNOSTIC DIVISION
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEIR METER KEEPS SHOWING ERR. A REVIEW OF THE SYSTEM WAS CONDUCTED OVER THE PHONE. THIS REVIEW INDICATED THAT SEGMENTS WERE MISSING FROM THE DISPLAY. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR FURTHER EVAL AND A REPLACEMENT WAS PROVIDED. THE CUSTOMER WAS INVITED TO CALL 24/7 FOR FUTURE QUESTIONS/CONCERNS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN