BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS LYME IGM

    MDR report key: 4786053 · Received May 20, 2015

    Report

    Report Number
    3002769706-2015-00027
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    November 1, 2014
    Report Date
    May 20, 2015
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    LSR
    PMA / PMN Number
    K122979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BIOMERIEUX REGARDING A FALSE POSITIVE RESULT ASSOCIATED WITH A NATIONAL QUALITY CONTROL (CNQ) EXERCISE PERFORMED IN (B)(6) 2014. THE IGM RESULT FOR THIS SAMPLE WAS EXPECTED TO BE NEGATIVE. THE VIDAS LYME IGM TEST, REF. 30319 GAVE A POSITIVE RESULT WHILE THE REAGENTS FOR OTHER COMPANIES GAVE THE EXPECTED NEGATIVE RESULT. CNQ IS AN EXTERNAL QUALITY CONTROL SCHEME ORGANIZED BY ANSM ON AN ANNUAL BASIS. IT CONSISTS OF SEVERAL BLIND SAMPLES WHICH ARE TESTED BY DIFFERENT CUSTOMERS ON THE SAME TECHNIQUE WITH THE AIM OF COMPARING THE RESULTS AND VALIDATE THE TECHNIQUE. THE L3 SAMPLE OF THE NATIONAL QUALITY CONTROL (CNQ) EXERCISE IS COMPOSED OF LYOPHILIZED PLASMA OF ONE PATIENT. THE VIDAS LYME IGM (LYM) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IGM ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN HUMAN SERUM OR PLASMA, TO AID IN THE DIAGNOSIS OF LYME DISEASE. THE REPORTED VIDAS LYME IGM, REF. (B)(4), IS NOT SOLD OR DISTRIBUTED WITHIN THE UNITED STATES; HOWEVER, A SIMILAR VIDAS LYME IGM ASSAY, REF (B)(4), IS SOLD AND DISTRIBUTED WITHIN THE UNITED STATES. AN INVESTIGATION WAS INITIATED AND THE FALSE POSITIVE RESULT WAS CONFIRMED WHEN TESTED WITH 2 DIFFERENT LOT NUMBERS OF THE REAGENT DAS LYME IGM. AN INTERFERENCE BETWEEN THE REAGENT AND THE SAMPLE L3 IS SUSPECTED. A SUBSEQUENT CAPA HAS BEEN INITIATED TO DETERMINE THE EXACT ROOT CAUSE AND PROPOSE CORRECTIVE / PREVENTIVE ACTIONS. THE CAPA IS ONGOING AND FURTHER TESTING IS PLANNED TO UNDERSTAND THE ROOT CAUSE OF THE ISSUE. THE MOST PROBABLE ROOT CAUSE IS A CROSS-REACTIVITY INTERFERENCE OF THE VIDAS LYME IGM REAGENT WITH THE SERUM IN SAMPLE L3. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), COSS-REACTIVITY MAY BE OBSERVED WITH CERTAIN DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328182 VIDAS LYME IGM REAGENT, BORRELIA SEROLOGICAL REAGENT LSR BIOMERIEUX, S.A. 1003226620

    Patients

    Seq Age Sex Outcome Treatment
    1