BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW

    MDR report key: 3813274 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00181
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LCP
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    AN HCP RECEIVED A PATIENT TEST RESULT OF 8.5% ON THE A1CNOW. A LAB TEST WAS ALSO PERFORMED AND THE READING WAS 5.5%. THE DIFFERENCE BETWEEN THE COMPARISON TESTS COULD BE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S A1CNOW KIT IS TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289324 A1CNOW PROFESSIONAL A1C SYSTEM LCP BAYER HEALTHCARE LLC 3021 1326738

    Patients

    Seq Age Sex Outcome Treatment
    1