BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMERIEUX VIDAS RUBELLA IGG KIT

    MDR report key: 1531947 · Received November 12, 2009

    Report

    Report Number
    MW5013514
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    June 1, 2009
    Report Date
    November 12, 2009
    Manufacturer
    BIOMERIEUX
    Product Code
    LFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    SINCE THE NEW GENERATION OF RUBELLA RELEASED FOR SALE BY THE MFR IN 2009, I HAVE BEEN GETTING AN UNUSUALLY HIGH NUMBER OF PTS WHO TEST AS EQUIVOCAL. BECAUSE I WAS SUSPICIOUS OF THESE RESULTS, I SENT THE SAMPLES INTO ANOTHER LAB FOR CONFIRMATION. I HAVE HAD 50 SAMPLES THAT DID NOT CONFIRM. I HAVE REPORTED IT TO THE COMPANY AND IN OVER 5 MONTHS THEY HAVE NOT RESOLVED THE PROBLEM. THREE MONTHS LATER, I SENT IN 8 SAMPLES AT THEIR REQUEST FOR CONFIRMATIONS. NOW, NEARLY 6 WEEKS LATER, I STILL HAVE NOT GOTTEN THE RESULTS OF THOSE TESTS. IN ADDITION TO THE EQUIVOCAL RESULTS, I HAVE HAD 3 OR 4 PTS WHO TESTED NON-REACTIVE WITH THEIR KIT AND CAME BACK REACTIVE WITH THE REFERENCE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMERIEUX VIDAS RUBELLA IGG KIT RUBELLA IGG LFX BIOMERIEUX ALL LOTS USED SINCE KIT CAME O

    Patients

    Seq Age Sex Outcome Treatment
    1