BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINISTIX

    MDR report key: 85207 · Received April 15, 1997

    Report

    Report Number
    MW4001857
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Report Date
    April 15, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    JIL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR SAID THAT THEIR OFFICE IS GETTING DRASTICALLY LONG RESPONSES ON THESE DIP STICKS FOR A PT WHO IS MONITORING HIS SUGAR, AND BLOOD MACHINE ALL SHOWED. A TRACE OR VERY LOW NUMBERS, UNLIKE THE DEVICE, THIS CAN COMPLETELY ALTER THE PT'S DOSAGE WHEN HE'S MONITORING HIMSELF. THIS IS A VERY DANGEROUS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINISTIX ENZYMATIC METHOD, GLUCOSE NON-QUANTITATIVE JIL BAYER CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *