BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 444996 · Received February 18, 2003

    Report

    Report Number
    1810909-2003-00083
    Event Type
    Malfunction
    Date Received
    February 18, 2003
    Date of Event
    January 21, 2003
    Report Date
    February 18, 2003
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED WITH A COMPLAINT THAT THEY WERE HAVING A HARD TIME READING THE NUMBERS ON THE SCREEN OF THEIR METER BECAUSE THEY WERE WAVY AND PARTS OF THE NUMBERS ARE MISSING. ALSO, THEY COMPLAINED THAT THEY WERE GETTING ERRATIC RESULTS. FOR EXAMPLE, THEY HAD A READING IN THE 400S MG/DL FOLLOWED 20 MINUTES LATER BY A READING IN THE 100S MG/DL. DURING THE TROUBLESHOOTING PROCESS, IT WAS DETERMINED THAT THERE MAY BE A PROBLEM WITH THE DISPLAY. PROPER TECHNIQUE WAS REVIEWED WITH THE CUSTOMER. THE CUSTOMER ALSO REQUESTED A NEW METER WITH A LARGER SCREEN. A REQUEST WAS MADE TO HAVE THE METER RETURNED FOR EVAL. IN THE MEANTIME, A REPLACEMENT UNIT WAS PROVIDED. THE CUSTOMER HAS ALSO BEEN INVITED TO CONTACT CO'S 24/7 CUSTOMER SERVICE LINE SHOULD ANY PROBLEMS OR QUESTIONS ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE XL BLOOD GLUCOSE METER NBW ARKRAY, INC. 3901A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN