BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW SELFCHECK

    MDR report key: 3223539 · Received July 12, 2013

    Report

    Report Number
    1826988-2013-00319
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LCP
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. THE INITIAL REPORTER PHONE AND ADDRESS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    A HOME CARE NURSE FROM (B)(6) REPORTED PATIENTS' RESULTS ON THE A1CNOW SELFCHECK SYSTEM WERE HIGHER THAN THE LAB TESTS. ONE PATIENT RECEIVED A 7.0% FROM THE A1CNOW, AND THE LAB TESTS WERE USUALLY 5.6 AND 5.8%. A SECOND PATIENT RECEIVED A 6.4% FROM THE A1CNOW AND THE LAB TEST WAS 5.1% A THIRD PATIENT RECEIVED 8.6% FROM THE A1CNOW AND THE LAB TEST WAS 6.9% THE DIFFERENCES BETWEEN THE TESTS COULD BE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE NURSE HAD NO PRODUCT LEFT TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323996 A1CNOW SELFCHECK AT-HOME A1C SYSTEM LCP BAYER HEALTHCARE LLC 3026 1127668

    Patients

    Seq Age Sex Outcome Treatment
    1