BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGG

    MDR report key: 8065985 · Received November 13, 2018

    Report

    Report Number
    3002769706-2018-00238
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 9, 2018
    Report Date
    March 27, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A REPORT FROM A CUSTOMER IN BELGIUM REGARDING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGG ASSAY (LOT 1006571330). INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE MANUFACTURING BATCH RECORDS FOR VIDAS® LYME IGG ASSAY LOT 1006571330 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. ALL THE RESULTS WERE WITHIN ACCEPTABLE RANGES AND VIDAS LYG BATCH 1006571330 IS COMPLIANT TO THE PRODUCT SPECIFICATIONS. INVESTIGATIONAL TESTING INCLUDED: INTERNAL SAMPLES: 6 SAMPLES PANEL WERE TESTED ON VIDAS LYME IGG 1006571330. ALL THE SAMPLES WERE WITHIN THEIR SPECIFICATIONS AND DIDN'T SHOW ANY EVOLUTION OVER TIME OF VIDAS LYME IGG BATCH 1006571330 ACTIVITY SINCE ITS RELEASE. INTERNAL QUALITY CONTROL SAMPLE: A SAMPLE OF ACCURUN 130 WAS TESTED ON VIDAS LYME IGG BATCH 1006571330, AND A POSITIVE RESULT WAS OBTAINED AS EXPECTED. PATIENT SAMPLE: THE PATIENT SAMPLE WAS FOUND NEGATIVE ON VIDAS LYME IGG BATCH 1006571330 WITH AN INDEX= 0.5 TV (POSITIVE THRESHOLD >=0.20 TV). THIS SAMPLE WAS TESTED BY BIOMNIS (EXTERNAL LABORATORY) USING MIKROGEN IGG WESTERN BLOT METHOD; PRESENCE ONLY OF A NONSPECIFIC BAND (ANTIP41) LEADING TO A NEGATIVE SCORE. BIOMNIS CONCLUDED TO ABSENCE OF IGG ANTIBODIES AGAINST BORRELIA IN THE SERUM. MOREOVER, AN ANTIBIOTIC THERAPY HAS BEEN UNDERGONE ON (B)(6) 2018 AND THIS COULD EXPLAIN THE WEAK KINETIC OF THE IGG ANTIBODIES. IN VIDAS LYME IGG REF. 30320 PACKAGE INSERT, IT IS MENTIONED AT SECTION LIMITATIONS OF THE METHOD: "PATIENTS IN THE EARLY STAGES OF INFECTION OR WHO HAVE UNDERGONE AN ANTIBIOTIC THERAPY, MAY NOT PRODUCE MEASURABLE IGM AND IGG. PATIENTS WITH CLINICAL HISTORY AND/OR SYMPTOMS SUGGESTIVE OF LYME BORRELIOSIS BUT WITH NEGATIVE TEST RESULTS SHOULD BE REPORTED AS NO DETECTABLE ANTIBODIES TO B.BURGDOFERI. A SECOND SPECIMEN SHOULD BE COLLECTED 4-6 WEEKS LATER." ADDITIONALLY, IN THE SECTION PERFORMANCE, THE SENSITIVITY CLAIMED IS AS FOLLOWS (RESULTS COMING FROM 2 STUDY): FOR ERYTHEMA MIGRANS STAGE : THE SENSITIVITY IS BETWEEN 51% [IC 95 : 36.3-65.6] AND 58.2% [IC95 : 44.1-71.4]. FOR NEUROBORRELIOSIS : 90.0% [IC 95 : 79.5-96.2] AND 91.4% [IC 95 : 82.3-96.8]. FOR ARTHRITIS/ ACCRODERMATITIS : 100.0% [IC 95 : 92.5-100.0] AND 96.1% [IC 95 : 86.5-99.5]. THE INVESTIGATION CONCLUDED THAT THE VIDAS® LYME IGG ASSAY ( LOT 1006571330) IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGG ASSAY ( LOT 1006571330). ON (B)(6) 2018, THE CUSTOMER RECEIVED A CEREBROSPINAL FLUID (CSF) SAMPLE TO TEST FOR NEUROBORRELIOSIS. THEY ALSO ASKED THE NEUROLOGIST FOR SERUM (BLOOD) TO TEST FOR INTRATHECAL IGG SYNTHESIS. THE VIDAS LYME IGG TEST WAS PERFORMED ON BOTH SAMPLES (CSF AND BLOOD), AND BOTH RESULTS WERE NEGATIVE. THE BLOOD SAMPLE WAS NEGATIVE WITH AN INDEX AT 0.15, AND THE CSF SAMPLE HAD AN INDEX AT -0.02, WITH INTRATHECAL IGG ANTIBODY PRODUCTION INDEX (IAP) OBTAINED AT 0. THE CSF DID NOT INDICATE ANY SIGN OF INFLAMMATION (NORMAL NUMBER OF LYMPHOCYTES, NORMAL TOTAL PROTEIN). THEREFORE THE CUSTOMER CONCLUDED THAT THERE WAS NO INTRATHECAL SYNTHESIS OF LYME IGG ANTIBODIES. THE NEUROLOGIST THEN SENT THE SAMPLES TO A PRIVATE LABORATORY: BOTH SAMPLES WERE POSITIVE TWICE WITH THE LIAISON® VLSE (VARIABLE MAJOR PROTEIN-LIKE SEQUENCE EXPRESSED) METHOD. THE FIRST SAMPLE WAS OBTAINED AT 20 AU/ML AND THE CONSECUTIVE SAMPLE WAS OBTAINED AT 40 AU/ML (POSITIVE AS OFF 10-15 AU/ML). THE CUSTOMER ALSO TESTED THE SAMPLE WITH VIDAS LYME IGM AND THE RESULT WAS POSITIVE. A WESTERN BLOT ASSAY WAS PERFORMED FOR BOTH IGG AND IGM, AND BOTH WERE POSITIVE. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903629 VIDAS® LYME IGG VIDAS® LYME IGG LSR BIOMERIEUX SA 1006571330

    Patients

    Seq Age Sex Outcome Treatment
    1