BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHIN H PYLORI

    MDR report key: 1744471 · Received June 29, 2010

    Report

    Report Number
    MW5016567
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 28, 2010
    Manufacturer
    INVERNESS
    Product Code
    LYR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS USING HENRY SCHEIN H PYLORI KIT FOR MY PROFICIENCY TESTING. I GOT NEGATIVE FOR BOTH SAMPLES. SAMPLE HPY-03 SHOULD HAVE BEEN POSITIVE. I PERFORMED MY PROFICIENCY SAMPLES ON A CLARITY H. PYLORI KIT AND GOT POSITIVE FOR HPY-03. THIS HAS BEEN REPORTED TO THE HENRY SCHEIN SALES REP AND TO (B)(4). THE HENRY SCHEIN KIT HAS BEEN REPLACED WITH THE CLARITY H PYLORI KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHIN H PYLORI H PYLORI KIT LYR INVERNESS HP9110019

    Patients

    Seq Age Sex Outcome Treatment
    1