BEUDAMED
    FDA Adverse Event Summary report: N

    FIRST CHOICE BLOOD GLUCOSE REAGENT STRIP

    MDR report key: 12250 · Received March 24, 1994

    Report

    Report Number
    MW1001207
    Date Received
    March 24, 1994
    Date of Event
    March 16, 1994
    Report Date
    March 16, 1994
    Manufacturer
    POLYMER TECHNOLOGY INTL.
    Product Code
    CFR
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT IN REAGENT STRIPS AND INDICATED THE STRIPS RECORDED TOO HIGH VERSUS A NORMAL SOLUTION. EVIDENTLY SHE TESTED THESE STRIPS ON HER MACHINE WITH A FRIEND'S STRIPS ON SOME "NORMAL" SOLUTION. THE MFR'S PRODUCT READ 170-175 WITH THE NORMAL SOLUTION AND THE OTHER PRODUCT 104-105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST CHOICE BLOOD GLUCOSE REAGENT STRIP CFR POLYMER TECHNOLOGY INTL.

    Patients

    Seq Age Sex Outcome Treatment
    1 *