BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGM (LYM)

    MDR report key: 17350368 · Received July 19, 2023

    Report

    Report Number
    8020790-2023-00046
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K122979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN ITALY THAT THEY OBTAINED POTENTIAL FALSE-NEGATIVE PATIENT RESULTS COMPARED TO OTHER METHODS WHEN USING VIDAS® LYME IGM (LYM) REFERENCE (B)(4) LOT 1009673180 (EXPIRY 06-OCT-2023). INVESTIGATION 1.DEVICE HISTORY RECORD NO ANOMALY WAS FOUND DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. 2. COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 3. TESTS/ANALYSIS PERFORMED TWO (2) SAMPLES IDENTIFIED 1 AND 2 WERE RECEIVED FROM THE CUSTOMER. SAMPLES WERE THAWED ON RECEIPT. COMPLAINTS LABORATORY PERFORMED SEVERAL TESTS : 3.1. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT : - ON FOUR (4) INTERNAL SERA VIDAS LYM WITH TARGETS BETWEEN 0.11 TO 2.42 VT. - ON SEVEN (7) BATCHES OF VIDAS LYM INCLUDING THE BATCHES MENTIONED BY THE CUSTOMER. ALL VALUES ARE WITHIN THEIR SPECIFICATIONS, CUSTOMER¿S LOT IS IN THE TREND OF THE OTHER LOTS. 3.2. STUDY ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES WITH FOLLOWING TARGETS: 0.39 VT, 0.34 VT, 0.11 VT AND 2.29 VT ON THE RETAIN KIT VIDAS LYM 1009673180. => SAMPLE RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS. NO BATCH CHANGES OBSERVED SINCE THE RELEASE DATE. 3.2. STUDY ON CUSTOMER SAMPLES: 3.2.1 TEST ON THE RETAIN KITS VIDAS LYM (B)(4). THE RESULTS OF SAMPLES 1 AND 2 WERE NEGATIVE FOR THIS BATCH. 3.2.2 TEST ON ANOTHER METHOD - KITS RECOMLINE® BORRELIA IGG ET IGM THE RESULTS OF SAMPLES 1 AND 2 WERE NEGATIVE. 4. ROOT CAUSE ANALYSIS AND CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED DURING THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED WITH THE RETAIN KIT FOR VIDAS LYM (B)(4). THE SAMPLES WERE NEGATIVE WITH 3 METHODS: VIDAS LYM AND RECOMLINE® BORRELIA (BOTH CONFIRMED DURING BIOMÉRIEUX INVESTIGATION) AS WELL AS WITH CHEMILUMINESCENCE SYNLAB AND POSITIVE WITH WESTERN BLOT EUROLINE EUROIMMUN (TWO (2) LAST RESULTS GIVEN BY THE CUSTOMER). THE WESTERNBLOT EUROLINE EUROIMMUN METHOD SHOWS 4 POSITIVE BANDS (OSPC BA, BB, BG AND BSP), BUT THEY ARE THE SAME ANTIGENIC COMMUNITY (OSPC). GIVEN THE DATA PROVIDED, THE PROBABLE CAUSE OF THIS DISCREPANCY IS AS FOLLOWS: 1/ ANTIBODIES MAY NOT PRESENT IN A DETECTABLE QUANTITY. IN THE EARLY STAGE, AN ANTIBIOTIC TREATMENT MAY PREVENT THE DEVELOPMENT OF DETECTABLE ANTIBODIES. IT IS ESTIMATED THAT IN 50% OF SUBJECTS IN THE PRIMARY STAGE OF DISEASE, ANTIBODY LEVELS REMAIN BELOW THE DETECTABLE THRESHOLD. THE PATIENT HAD TICK BITE IN EARLY JUNE AND THE VIDAS TESTS WERE CARRIED OUT IN MID-JUNE AND AT THE END OF JUNE. PATIENT WAS TREATED WITH ANTIBIOTICS. 2/ POSSIBILITY OF FALSE POSITIVE RESULTS OF WESTERN BLOT EUROLINE EUROIMMUN. ACCORDING TO THE VIDAS LYM PACKAGE INSERT: - RESULTS AND INTERPRETATION : IN CASE OF CLINICAL SUSPICION (TICK BITE, NEUROLOGICAL SYMPTOMS, ETC.), COLLECT ANOTHER SAMPLE LATER. - LIMITATIONS OF THE METHOD: 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, BUT WITH NEGATIVE TEST RESULTS, SHOULD BE REPORTED AS "NO DETECTABLE ANTIBODIES TO B. BURGDORFERI". A SECOND SPECIMEN SHOULD BE COLLECTED 4-6 WEEKS LATER BASED ON THE ABOVE DATA, THERE IS NO RECONSIDERATION OF PERFORMANCE OF VIDAS® LYME IGM (LYM) (B)(4).

    Description of Event or Problem · 0

    PRODUCT DESCRIPTION: THE VIDAS® LYME IGM (LYM) (REF. 30319) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IGM ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN HUMAN SERUM OR PLASMA, TO AID IN THE DIAGNOSIS OF LYME DISEASE. INTERPRETATION OF RESULTS FOR LYME IGM: INDEX INTERPRETATION: I < 0.20 NEGATIVE. 0.20 = I < 0.32 EQUIVOCAL. I = 0.32 POSITIVE. ISSUE DESCRIPTION: ON (B)(6) 2023, A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF POTENTIAL FALSE-NEGATIVE PATIENT RESULTS COMPARED TO OTHER METHODS WHEN USING VIDAS® LYME IGM (LYM) REFERENCE 30319 LOT 1009673180 (EXPIRY 06-OCT-2023). PATIENT INFORMATION: PATIENT HAD TICK BITE IN EARLY JUNE. THE PATIENT DEVELOPED MENINGITIS. PATIENT WAS TREATED WITH ANTIBIOTICS. MENINGITIS RESOLVED BUT PATIENT CONTINUED TO HAVE HEALTH PROBLEMS. TEST RESULTS: (B)(6) 2023 ON MINIVIDAS, LYM NEGATIVE (TV 0.15), LYG NEGATIVE (TV 0.08), (B)(6) 2023 WESTERNBLOT EUROLINE EUROIMMUN. LYM POSITIVE, LYG NEGATIVE. (B)(6) 2023 ON VIDAS. LYM NEGATIVE (TV 0.10), LYG NEGATIVE TV 0.14, (B)(6) 2023 CHEMILUMINESCENCE SYNLAB. LYM NEGATIVE (TV 0.2), LYG NEGATIVE (TV 27.8), (B)(6) 2023 WESTERNBLOT EUROLINE EUROIMMUN. LYM POSITIVE, LYG NEGATIVE, AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. THE PRODUCT, VIDAS® LYME IGM (LYM) (REF. 30319), IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, A SIMILAR PRODUCT, VIDAS® LYME IGM II (LYM (REF. 416436) IS SOLD IN THE UNITED STATES. A BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39469 VIDAS® LYME IGM (LYM) VIDAS® LYME IGM (LYM) LSR BIOMÉRIEUX SA 1009673180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown