BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 401194 · Received June 13, 2002

    Report

    Report Number
    1810909-2002-00110
    Event Type
    Other
    Date Received
    June 13, 2002
    Date of Event
    May 16, 2002
    Report Date
    June 11, 2002
    Manufacturer
    ARKRAY, INC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT STATED THAT THE GLUCOMETER ELITE SYSTEM PROVIDED A BLOOD GLUCOSE RESULT OF "LO" (LESS THAN 20 MG/DL). A REPEAT TEST DONE IMMEDIATELY AFTER THE "LO" RESULT GAVE A RESULT OF 5.7 MMOL/L OR 103 MG/DL. THE DIFFERENCE COULD BE CLINICALLY SIGNIFICANT. WHILE ON THE PHONE A REVIEW OF THE OPERATION OF THE SYSTEM WAS CONDUCTED. THE CUSTOMER WAS UNAWARE WHEN THE METER BEGAN TO READ RESULTS IN MMOL/L RATHER THAN MG/DL. THE UNITS OF MEASURE WERE CHANGED. ELECTRONIC CHECKS WERE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 DATE BLOOD GLUCOSE METER NBW ARKRAY, INC 3901B *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other