BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 1031888 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00401
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE RECEIVED A BLOOD GLUCOSE RESULT THAT WAS HIGHER THAN USUAL. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 205 MG/DL. THE NORMAL CONTROL RANGE WAS 72-104 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE CONTACTED THE CUSTOMER AFTER THE INITIAL CALL TO REMIND HIM TO RETURN HIS TEST STRIPS FOR EVALUATION. THE CUSTOMER STATED THAT HE HAD DISPOSED FOR THE TEST STRIPS, SO NO PRODUCT COULD BE RETURNED. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 DATE BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3901B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK