BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGG

    MDR report key: 8214200 · Received January 3, 2019

    Report

    Report Number
    8020790-2019-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN FRANCE REPORTING FALSE NEGATIVE RESULTS WHEN USING THE VIDAS® LYME IGG ASSAY, LOT 1006571330 AND LOT 1006179040. **COMPLAINT TRENDING ANALYSIS** ONE OTHER COMPLAINT FOR EACH LOT OF VIDAS LYG (1006179040/181125-0 AND 1006571330/190530-0) WERE REPORTED. ** QUALITY CONTROL RECORDS ** THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS LYG BATCHES 1006179040/181125-0 AND 1006571330/190530-0 SHOWED NO ANOMALY DURING MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO CAPA NOR NON CONFORMITY WAS RECORDED FOR EITHER OF THESE TWO LOTS. ** STUDY OF INTERNAL SAMPLES CONTROL CHARTS** AN ANALYSIS WAS CARRIED OUT ON SIX INTERNAL POSITIVE SAMPLES, THAT INCLUDED THREE WITH HIGH TEST VALUES AND THREE SAMPLES WITH TEST VALUES CLOSE TO THE CUT-OFF OF 0.20 TV. VIDAS LYG BATCHES 181125-0 AND 190530-0 WERE COMPARED TO FOUR OTHER BATCHES (190104-0, 190312-0, 190619-0 AND 190821-0), AND ALL RESULTS FOR ALL BATCHES WERE WITHIN ACCEPTABLE RANGES AND COMPLIANT TO THE PRODUCT SPECIFICATIONS. **TESTS PERFORMED INTERNALLY** SIX INTERNAL SAMPLES WERE TESTED ON VIDAS LYG BATCH 1006179040 / 181125-0 (TEST PERFORMED ON SEPTEMBER 2018) AND BATCH 1006571330 /190530-0 (TEST PERFORMED ON NOVEMBER 2018) , AND COMPARED TO TWO OTHER BATCHES MANUFACTURED USING DIFFERENT RAW MATERIAL. VIDAS LYG BATCHES 1006179040 / 181125-0 AND 1006571330 / 190530-0 WERE WITHIN THEIR ACCEPTABLE RANGES. THERE WAS NO INTERPRETATION CHANGE AND THE RESULTS OBTAINED WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCH RELEASE. THE BLOOD SAMPLES FROM THE PATIENT THAT WERE COLLECTED RESPECTIVELY IN MAY2018 AND SEP2018 WERE NEGATIVE, USING BATCHES OF VIDAS LYME IGG 190530-0 AND THREE OTHER BATCHES, WITH RESULTS BETWEEN 0.12 AND 0.19 TV ( CUT-OFF >=0.20). THE PATIENT SAMPLES WERE NOT TESTED ON VIDAS LYME IGG BATCH 1006179040 / 181125-0 BECAUSE THE LOT WAS EXPIRED WHEN THE SAMPLES WERE RECEIVED. ACCORDING TO THE RESULTS PROVIDED BY THE CUSTOMER, THE SAMPLE COLLECTED ON MAY2018 WAS EQUIVOCAL USING DIASORIN AND LYME IGM NEGATIVE. THE WESTERN BLOT (MIKROGEN METHOD) GAVE A SCORE OF 6 POINTS (POSITIVE RESULT IF >= 7 POINTS). BIOMNIS CONCLUDED TO AN INCOMPLETE PROFILE WHICH DOESN'T ALLOW TO CONFIRM THE PRESENCE OF SPECIFIC IGG ANTIOBODIES IN THE SERUM. TO SEE WITH THE CLINICAL AND THERAPEUTIC CONTEXT. THE SAMPLE COLLECTED ON SEP2018 WAS POSITIVE USING DIASORIN WITH AN IGG CONCENTRATION OF 15 UA/ML (CUT-OFF =14 UA/ML) AND LYME IGM NEGATIVE. THE WESTERN BLOT (MIKROGEN METHOD) GAVE A SCORE OF 6 POINTS (POSITIVE RESULT IF >= 7 POINTS). BIOMNIS CONCLUDED TO AN INCOMPLETE PROFILE WHICH DOESN'T ALLOW TO CONFIRM THE PRESENCE OF SPECIFIC IGG ANTIOBODIES IN THE SERUM. TO SEE WITH THE CLINICAL AND THERAPEUTIC CONTEXT. AFTER THE RESULTS OBTAINED BY THE CUSTOMER IN MAY, AN ANTIBIOTIC THERAPY WAS STARTED IN JUNE FOR THREE WEEKS WITH CEFTRIAXONE, WHICH MAY EXPLAIN THE WEAK KINETICS OF THE IGG ANTIBODIES IN THE SERUM. THE CSF SAMPLES WERE NOT TESTED USING VIDAS LYME IGG METHOD, SO NO INFORMATION WAS OBTAINED REGARDING THEIR BEHAVIOR ON VIDAS. IN CONCLUSION, THIS ISSUE COULD BE EXPLAINED BY THE PATIENT CONTEXT. (SUSPICION OF NEUROBORRELIOSIS AND ANTIBIOTIC THERAPY). ACCORDING TO THE INFORMATION, THERE IS NO ISSUE WITH THE PERFORMANCES OF VIDAS LYG BATCH 1006179040 /181125-0 AND BATCH 1006571330/190530-0 . 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".

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER IN (B)(6) REPORTED FALSE NEGATIVE RESULTS WHEN USING THE VIDAS® LYME IGG ASSAY, LOT 1006571330. THE CUSTOMER STATED THEY OBTAINED VIDAS® LYME IGG ASSAY NEGATIVE RESULTS FOR A (B)(6) YEAR-OLD MALE PATIENT 'S SAMPLES WITH THE IMPACTED LOT WHEN PERFORMING REPEAT TESTING IN (B)(6) 2018. THE CUSTOMER SENT THE PATIENT SAMPLES TO TWO EXTERNAL LABORATORIES, AND THE RESULTS 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
    5421 VIDAS® LYME IGG VIDAS® LYME IGG LSR BIOMERIEUX SA 1006571330

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR