BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW+

    MDR report key: 18777142 · Received February 23, 2024

    Report

    Report Number
    MW5151893
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 13, 2024
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC
    Product Code
    LCP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS A HOME A1C TEST KIT UNDER BRAND A1CNOW+. ONE BOX OF TEST KITS CONSISTENTLY DELIVERS A RESULT THAT IS 7 OR HIGHER. ONE BOX OF TEST KITS CONSISTENTLY DELIVERS A RESULT THAT IS 6 OR HIGHER. I DID A SIDE-BY-SIDE WHICH WAS BLOOD DRAWN SAME FINGER PIN PRICK AND THE A1C FOR ONE IS 7.4 AND THE OTHER IS 6.1. WHAT IS MORE ASTONISHING. IS THAT THIS ISN'T JUST ONE KIT MULTIPLE TESTS FROM THE SAME BOXES YIELD SIMILAR RESULTS. THE WHOLE BOX IS OFF. NOT JUST ONE TEST. THIS POINTS TO A BIGGER ISSUE. A QUICK GOOGLE SEARCH SAYS IT IS 97.8% ACCURATE TO DOCTOR TESTS. IMPOSSIBLE. REFERENCE REPORT: #MW5151894.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539028 A1CNOW+ ASSAY, GLYCOSYLATED HEMOGLOBIN LCP POLYMER TECHNOLOGY SYSTEMS, INC A1CNOW+ 2224524

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PRILOSEC.| STATIN.| WEGOVY.