BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGM

    MDR report key: 9433064 · Received December 6, 2019

    Report

    Report Number
    8020790-2019-00071
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Report Date
    March 19, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K122979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR A CUSTOMER COMPLAINT OF FALSE NEGATIVE IGM RESULTS WHEN TESTING A PATIENT SAMPLE WITH VIDAS® LYME IGM ASSAY (REF 30319, LOT 1007297710/200330-0) AND COMPARING TO THE WESTERN BLOT IGM RESULTS THAT OBTAINED BORDERLINE POSITIVE RESULTS. THE CUSTOMER SUBMITTED THE PATIENT¿S SAMPLE FOR THE INVESTIGATION. THE ANALYSIS OF QUALITY CONTROL RECORDS FOR VIDAS LYME IGM LOT 1007297710 / 200330-0 SHOWED NO ANOMALY IN RELATION WITH THE OBJECT OF THIS COMPLAINT. THE RESULTS FROM TESTING FOUR INTERNAL SAMPLES ON THE RETAINED KIT OF VIDAS LYME IGM 1007297710 / 200330-0 WERE ACCEPTABLE AND SIMILAR TO THOSE BEFORE THE BATCH RELEASE. NO OBSERVED EVOLUTION OVER TIME SINCE THE BATCH RELEASE. TESTING THE PATIENT¿S SAMPLE REPRODUCED THE CUSTOMER'S NEGATIVE RESULT WITH TWO DIFFERENT LOTS OF VIDAS LYM IGM(CUSTOMER'S LOT AND A LOT MANUFACTURED WITH DIFFERENT RAW MATERIAL BATCH, 1007761340 / 201113-0). THE SAMPLE WAS ALSO NEGATIVE WITH VIDAS LYME IGG LOT 1007253140. THE NEGATIVE INTERPRETATION OBTAINED WITH VIDAS LYME IGM WAS CONFIRMED WHEN TESTING THE SAMPLE ON LYMECHECK OPTIMA. THE INVESTIGATION CAN ONLY OBSERVE A FAINT LINE CORRESPONDING TO FLAGELLIN (P41), UNDER THE POSITIVE THRESHOLD. CONCLUSION: IT IS POSSIBLE THAT THE PATIENT¿S ANTIBIOTIC THERAPY IMPACTED THE ANTIBODIES KINETIC IN TERM OF CONCENTRATION AND DIVERSITY. IT IS NOTED IN THE VIDAS LYME IGM PACKAGE INSERT, THE FOLLOWING INFORMATION, "NEGATIVE RESULTS WITH THE VIDAS® LYME IGM AND VIDAS® LYME IGG ASSAYS DOES NOT RULE OUT THE POSSIBILITY OF B. BURGDORFERI INFECTION IN A PATIENT. PATIENTS IN THE EARLY STAGES OF INFECTION OR WHO HAVE UNDERGONE ANTIBIOTIC THERAPY, MAY NOT PRODUCE MEASURABLE IGM AND IGG. PATIENTS WITH CLINICAL HISTORY AND / OR SYMPTOMS SUGGESTIVE OF LYME BORRELIOSIS, AIM WITH NEGATIVE TEST RESULTS, SHOULD BE REPORTED AS "NO DETECTABLE ANTIBODIES TO B. BURGDORFERI." A SECOND SPECIMEN OF THE FILE MANAGED SHOULD BE 4-6 WEEKS LATER.¿ BASED ON THE INVESTIGATION, PERFORMANCE OF VIDAS LYME IGM LOT 1007297710 / 200330-0 IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE IGM RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGM 60 TESTS (REF 30319, LOT 1007297710) WHEN TESTING A PATIENT SAMPLE AND COMPARING TO THE WESTERN BLOT IGM RESULTS THAT OBTAINED BORDERLINE POSITIVE RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT SUSPECTED HE WAS BITTEN BY A TICK ON (B)(6) 2019. THE BITE LOCATION WAS RED AND DID NOT DISAPPEAR FOR A FEW DAYS. ON (B)(6) 2019, THE PATIENT CONSULTED HIS DOCTOR AND AN ANTIBIOTIC TREATMENT WAS PRESCRIBED FOR 28 DAYS. THE DOCTOR RECOMMENDED TO THE PATIENT TO PERFORM LYME TESTING SIX (6) WEEKS AFTER THE ANTIBIOTIC TREATMENT WAS STARTED. ON (B)(6) 2019, TESTS WERE PERFORMED WITH VIDAS LYME IGM 60 TESTS, BATCH 1007297710, AND THE RESULTS WERE AS FOLLOWS: IGM (TV = 0.01) : NEGATIVE. IGG (TV = 0.02) : NEGATIVE. IT WAS MENTIONED BY THE CUSTOMER THAT THE CALIBRATIONS WERE EXPIRED FOR THESE TESTS. A WESTERN BLOT TEST WAS ALSO PERFORMED AND THE RESULTS WERE AS FOLLOWS: IGM : POSITIVE (REPORTED AS BORDERLINE BY THE CUSTOMER). IGG: NEGATIVE. ON (B)(6) 2019, THE PATIENT WAS TESTED AGAIN WITH THE VIDAS LYME IGM 60 TESTS, BATCH 1007297710 (CORRECT CALIBRATION), AND THE RESULTS WERE AS FOLLOWS: IGM (TV = 0.01) : NEGATIVE. IGG (TV = 0.02) : NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE IGM RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224286 VIDAS® LYME IGM VIDAS LYME IGM 60 TESTS - 30319 LSR BIOMERIEUX SA 1007297710

    Patients

    Seq Age Sex Outcome Treatment
    1