BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGM II

    MDR report key: 6226239 · Received January 5, 2017

    Report

    Report Number
    3002769706-2017-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Report Date
    February 15, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LYR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. A REVIEW OF QUALITY RECORDS FOR VIDAS® LYME IGM II LOT 1004988230 CONFIRMED THE LOT MET THE MANUFACTURING CRITERIA AND THERE WERE NO SIMILAR ISSUES. FIVE (5) RESERVE SAMPLES WERE TESTED FROM THE LOT. (TARGET: VT : 1.22, 0.22 , 2.42, 0.01, AND 0.01) ALL TEST RESULTS FOR EACH SAMPLE WERE WITHIN THE EXPECTED SPECIFICATIONS. ACCORDING TO THE WB PACKAGE INSERT (VIRAMED BIOTECH AG - BORRELIA B31 IGM VIRASTRIPE®), IT USED THE STRAIN BORRELIA BURGDORFERI SENSU STRICTO (AMERICAN STRAIN BORRELIA). THE VIDAS® LYME IGM II USED RECOMBINANT ANTIGENS FROM BORRELIA BURGDORFERI SENSU STRICTO, B AFZELII AND B GARINII. THE VIDAS® LYME IGM II PACKAGE INSERT STATES: "LIMITATIONS OF THE METHOD": A NEGATIVE RESULT IN THE VIDAS® LYME IGM II ASSAY DOES NOT RULE OUT THE POSSIBILITY OF B. BURGDORFERI INFECTION IN A PATIENT. PATIENTS IN EARLY STAGES OF INFECTION OR WHO HAVE UNDERGONE ANTIBIOTIC THERAPY, MAY NOT PRODUCE MEASURABLE ANTIBODIES. PATIENTS WITH CLINICAL HISTORY AND/OR SYMPTOMS SUGGESTIVE OF LYME DISEASE, BUT WITH NEGATIVE TEST RESULTS, SHOULD BE REPORTED AS "NO DETECTABLE ANTIBODIES TO B. BURGDORFERI". A SECOND SPECIMEN SHOULD BE COLLECTED IN 4-6 WEEKS. NOTE: IT IS ESTIMATED THAT IN 50% OF SUBJECTS, IN THE PRIMARY STAGE OF DISEASE, ANTIBODY LEVELS IN BLOOD REMAIN BELOW THE DETECTABLE THRESHOLD (10). FURTHER INVESTIGATION IS NOT POSSIBLE WITHOUT THE CUSTOMER ISOLATE. THE VIDAS® LYME IGM II LOT 1004988230 PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX A FALSE NEGATIVE RESULT FOR SIX (6) SAMPLES IN ASSOCIATION WITH VIDAS® LYME IGM II TEST KIT. THE VIDAS® LYME IGM TEST RESULT WAS NEGATIVE FOR ALL 6 SAMPLES, ALTHOUGH 2 WERE KNOWN BY THE CUSTOMER TO BE POSITIVE. ALL SAMPLES WERE POSITIVE BY WESTERN BLOT, AND THE BANDS PRESENT FOR THE 2 KNOWN POSITIVES WERE BAND 23 (OSP C) AND BAND 41. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8282 VIDAS® LYME IGM II VIDAS® LYME IGM II LYR BIOMERIEUX SA 1004988230

    Patients

    Seq Age Sex Outcome Treatment
    1