BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW

    MDR report key: 3872296 · Received June 13, 2014

    Report

    Report Number
    1826988-2014-00201
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LCP
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    AN HCP REPORTED THAT A PATIENT'S RESULTS ON THE A1CNOW SYSTEM WERE 8.0 AND 7.4%. THE READING FROM THE LAB WAS 5.2%. THE DIFFERENCES BETWEEN THE TESTS COULD BE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE KIT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350027 A1CNOW PROFESSIONAL A1C SYSTEM LCP BAYER HEALTHCARE LLC 3021 1325251

    Patients

    Seq Age Sex Outcome Treatment
    1