BEUDAMED
    FDA Adverse Event Summary report: N

    LABSTIX

    MDR report key: 339721 · Received June 21, 2001

    Report

    Report Number
    1810909-2001-00036
    Date Received
    June 21, 2001
    Date of Event
    April 16, 2001
    Report Date
    June 21, 2001
    Manufacturer
    BAYER DIAGNOSTICS
    Product Code
    JIO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN FROM UK COMPLAINED THAT THE URINE GLUCOSE READINGS WERE READING FALSE NEGATIVE USING BAYER VISUAL REAGENT STRIPS PRODUCT, LABSTIX. PHYSICIAN CLAIMS THAT THE PT IS NOW IN SERIOUS RISK OF FALLING INTO A DIABETIC COMA. THE URINE AND BLOOD TESTS HAVE BEEN SENT TO THE LABORATORY AND CONFIRMED THAT THE PATIENT'S GLUCOSE LEVELS IN BLOOD SAMPLE ARE ABNORMALLY HIGH. IN HOUSE INVESTIGATION OF AFFECTED PRODUCT DID NOT CONFIRM THE ALLEGED COMPLAINT. THE PRODUCT CLAIMS CLEARLY INDICATE THAT THE PRODUCT IS INTENDED AS A SCREEN TEST TO IDENTIFY POTENTIAL DIABETICS WHO'S BLOOD GLUCOSE LEVELS ARE HIGH ENOUGH TO CAUSE TO SPILL GLUCOSE OVER THAT INDIVIDUAL'S THRESHOLD INTO THE URINE. THE PRODUCT IS NOT INTENDED TO MONITOR OR REGULATE A DIABETIC'S BLOOD GLUCOSE LEVEL. IT SEEMS TO BE THE APPROACH TAKEN BY THE PHYSICIAN WHO REPORTED THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28390 LABSTIX IVD - URINALYSIS-MULTIPLE VISUAL/GLUCOSE PARAMETERS JIO BAYER DIAGNOSTICS * 0E03C

    Patients

    Seq Age Sex Outcome Treatment
    1 *