BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGM II

    MDR report key: 5477912 · Received March 3, 2016

    Report

    Report Number
    3002769706-2016-00043
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 5, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K943812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMERIEUX PERFORMED AN INVESTIGATION INTO THE REPORT OF A FALSE NEGATIVE RESULT WITH THE VIDAS® LYME IGM II TEST KIT. THE CUSTOMER DID NOT RETURN THE SAMPLE THAT WAS IN QUESTION; THEREFORE, TWO(2) NEGATIVE, THREE (3) EQUIVOCAL, AND FOUR (4) POSITIVE QUALITY CONTROL SAMPLES WERE TESTED ON RETAINED SAMPLES FROM THE REPORTED LOT AS WELL AS A SECOND LOT. ALL RESULTS FROM THE QUALITY CONTROL SAMPLES WERE AS EXPECTED. BASED ON THE RESULTS OF THE INVESTIGATION, THE VIDAS® LYME IGM II TEST KIT IS OPERATING AS INTENDED WITHIN SPECIFICATION. ADDITIONALLY, THE CUSTOMER'S RESULTS COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES REPORTED FALSE NEGATIVE RESULTS FOR VIDAS® LYME IGM II LOT 1004140950. THE RESULTS OF THE INTERNAL BIOMÉRIEUX INVESTIGATION ARE AS FOLLOWS: NO OTHER COMPLAINT RELATED TO A FALSE NEGATIVE RESULT HAS BEEN REGISTERED ON THE VIDAS® LYME IGM II LOT 1004140950/160912-0. THERE IS NO CAPA OR NONCONFORMITY FOR VIDAS® LYME IGM II RELATED TO THIS ISSUE. THE ANALYSIS OF THE BATCH HISTORY RECORDS - NO ANOMALY RELATED TO THE CONTROL PROCESS. TESTING INCLUDED TWO (2) NEGATIVE, THREE (3) EQUIVOCAL AND FOUR (4) POSITIVE INTERNAL SAMPLES ON THE KIT RETAINED LOT 1004140950/160912-0 AND LOT 170321-0. THE RESULTS OBTAINED FOR THE NINE (9) INTERNAL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. THE ANALYSIS OF THE CONTROL CARD ON THESE NINE (9) SAMPLES SHOWS THAT VIDAS® LYME IGM II LOT 1004140950/160912-0 IS IN TREND WITH THE OTHER BATCHES. COMPARED TO THE RESULTS OBTAINED DURING THE RELEASE, THE VIDAS® LYME IGM II KIT LOT 1004140950/160912-0 HAS NOT EVOLVED SINCE THE RELEASE. THE VIDAS® LYME IGM II PACKAGE INSERT INDICATES 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. IN ADDITION, THE WESTERN BLOT METHOD IS MORE SENSITIVE THAN EIA TECHNIQUE, WHICH CAN EXPLAIN THE POSITIVITY OBSERVED ON THE WESTERN BLOT VERSUS THE VIDAS® ASSAYS IN THIS CASE. THIS CASE MOST LIKELY INVOLVES EARLY INFECTION AND THEREFORE, REPEAT TESTING IS NECESSARY AS DIRECTED IN THE PACKAGE INSERT. IN CONCLUSION, THE KIT VIDAS® LYME IGM II LOT 1004140950/160912-0 IS PERFORMING WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE NEGATIVE RESULT WHILE USING THE VIDAS® LYME IGM II. THE LYME IGM II WAS EQUIVOCAL WHICH WAS SENT OUT FOR CONFIRMATION. THE LYME IGM II THEN RETURNED A NEGATIVE RESULT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135042 VIDAS® LYME IGM II VIDAS® LYME IGM II LSR BIOMERIEUX SA 1004140950

    Patients

    Seq Age Sex Outcome Treatment
    1