BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS TOXO IGG II

    MDR report key: 10408405 · Received August 14, 2020

    Report

    Report Number
    8020790-2020-00069
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Report Date
    November 23, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ISRAEL REGARDING A FALSE POSITIVE TXG RESULT AS COMPARED TO SABIN-FELDMAN METHOD WHILE TESTING A PATIENT STRAIN USING THE VIDAS® TOXO IGG II TEST KIT (REFERENCE # (B)(4), LOT # 1007690000) AND ANOTHER PATIENT USING A SECOND LOT (REFERENCE # (B)(4), LOT # 1007857100). THE BATCH HISTORY RECORDS WERE REVIEWED AND SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THE COMPLAINT LABORATORY OBSERVED FOUR (4) INTERNAL SAMPLES ON SEVEN DIFFERENT LOTS OF VIDAS TXG II REF 30210 INCLUDING THE TWO CUSTOMER'S LOTS. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. BOTH CUSTOMER LOTS (VIDAS TXGII 1007690000/200912-0 AND 1007857100/201212-0) WERE IN THE TREND OF THE OTHER LOTS. THE COMPLAINT LABORATORY TESTED FOUR (4) INTERNAL SAMPLES WITH THE RETAIN KITS (VIDAS TXG II LOT 1007857100/201212-0, LOT 1007690000/200912-0 AND A THIRD LOT VIDAS TXGII 1008007940/210222-0). ALL INTERNAL SAMPLE RESULTS WERE WITHIN SPECIFICATIONS AND SIMILAR TO RESULTS OBTAINED BEFORE THE BATCHES WERE RELEASED. THIS SUPPORTS THAT THERE WAS NO DRIFT OF THE BATCHES SINCE THEIR RELEASES. THE CUSTOMER RETURNED TWO SAMPLES TO BE TESTED. THE CUSTOMER SAMPLES WERE TESTED ON RETAIN KITS (VIDAS TXG II LOT 1007857100/201212-0 AND LOT VIDAS TXGII 1008007940/210222-0). THE SAMPLES COULD NOT BE TESTED WITH THE CUSTOMER'S LOT (VIDAS TXGII 1007690000/200912-0) BECAUSE IT HAD EXPIRED BEFORE THE CUSTOMER'S SAMPLES WERE RECEIVED. BOTH RETURNED SAMPLES OBTAINED POSITIVE RESULTS ON THE TWO LOTS TESTED. A THIRD TECHNIQUE WAS PERFORMED ON THE TWO RETURNED SAMPLES AT AN EXTERNAL LABORATORY USING DIASORIN TEST ON LIAISON AND POSITIVE RESULTS WERE OBTAINED FOR BOTH. IN CONCLUSION, THE THIRD TECHNIQUE (DIASORIN) CONFIRMED THE POSITIVE RESULTS WITH VIDAS TXGII. THERE WAS NO ANOMALY HIGHLIGHTED WITH THE CONTROL CHART , THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON INTERNAL SAMPLES WITH VIDAS TXGII LOT 1007857100/201212-0 AND LOT 1007690000/200912-0. THEREFORE, THERE IS NO RECONSIDERATION OF THE LOTS (VIDAS TXGII LOT 1007857100/201212-0 AND LOT 1007690000/200912-0). BOTH LOTS OF VIDAS TXGII (LOT 1007857100/201212-0 AND LOT 1007690000/200912-0) ARE PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE TXG RESULT WHILE TESTING A PATIENT STRAIN USING THE VIDAS® TOXO IGG II TEST KIT (REFERENCE # (B)(4), LOT # 1007857100). ADDITIONAL INFORMATION HAS BEEN REQUESTED BY GLOBAL CUSTOMER SERVICE (GCS) FROM LOCAL CUSTOMER SERVICE (LCS) AND THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870569 VIDAS TOXO IGG II VIDAS® TOXO IGG II LGD BIOMERIEUX SA 1007857100

    Patients

    Seq Age Sex Outcome Treatment
    1