BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG II 60 TESTS

    MDR report key: 9702634 · Received February 12, 2020

    Report

    Report Number
    8020790-2020-00016
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF OBTAINING A FALSE NEGATIVE TOXOPLASMA IGG RESULT FOR A PREGNANT PATIENT¿S SERUM SAMPLE IN ASSOCIATION WITH VIDAS® TOXO IGG II 60 TESTS (REF. 30210, LOT: 1007539480). TWO (2) FROZEN SERUM SAMPLES IDENTIFIED AS (B)(4) WERE SUBMITTED FOR INVESTIGATIONAL TESTING. INVESTIGATIONAL TESTING WAS PERFORMED WITH VIDAS® TOXO IGG II 60 TESTS (REF 30210 LOT: 1007539480 / 200701-0) AND VIDAS® TOXO IGM LOT: 201003-0. THE OBTAINED RESULTS WERE THE FOLLOWING: SAMPLE RESULTS WITH VIDAS TOXO IGG II (B)(4): 21 IU/ML POSITIVE. (B)(4): 21 IU/ML POSITIVE. SAMPLES RESULTS WITH VIDAS TOXO IGM: (B)(4): 0.22 TV NEGATIVE. (B)(4): 0.21 TV NEGATIVE. THE CUSTOMER ANOMALY WAS NOT REPRODUCED WITH VIDAS TXG II (REF. 30210) LOT: 1007539480/ 200701-0. A COMPLAINT TREND ANALYSIS DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR SIMILAR ISSUES RELATED TO LOT: 1007539480/ 200701-0. REVIEW OF MANUFACTURING RECORDS DID NOT INDICATE ANY ISSUES DURING MANUFACTURING OF THIS LOT. THE MOST LIKELY CAUSE FOR THE CUSTOMER'S FIRST NEGATIVE RESULT HAS BEEN IDENTIFIED AS THE POTENTIAL ABSENCE OF SAMPLE IN THE STRIP OR THE ABSENCE OF SPR DURING THE TEST.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE TOXOPLASMA IGG RESULT FOR A PREGNANT PATIENT¿S SERUM SAMPLE IN ASSOCIATION WITH VIDAS® TOXO IGG II 60 TESTS (REF. 30210, LOT 1007539480). THE CUSTOMER INITIALLY TESTED THE PATIENT SERUM SAMPLE USING THE VIDAS® TOXO IGG ASSAY IN CONJUNCTION WITH THE MINIVIDAS® INSTRUMENT AND USING THE ALINITY ABBOTT TEST METHOD. THE VIDAS TOXO IGG ASSAY OBTAINED A NEGATIVE RESULT OF 0 IU/ML WHILE THE ALINITY TEST METHOD OBTAINED A POSITIVE RESULT. THE CUSTOMER ALSO TESTED THE SAMPLE FOR TOXOPLASMA IGM USING ALINITY ABBOTT AND BIORAD TEST METHODS. BOTH METHODS PROVIDED A RESULT OF POSITIVE. THE POSITIVE RESULT WAS CONFIRMED USING THE WESTERN BLOT TEST METHOD. THE PATIENT¿S SERUM SAMPLE WAS RETESTED USING VIDAS® TOXO IGG LOT 1007539480 AND OBTAINED A RESULT OF POSITIVE. THE CUSTOMER REPORTED THAT THE QCV TESTS ARE PERFORMED WEEKLY AND OBTAINED PASSING RESULTS DURING THE AFFECTED TIME. 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. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION. NOTE: REFERENCE 30210 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30210-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162828 VIDAS® TOXO IGG II 60 TESTS VIDAS® TOXO IGG II 60 TESTS LGD BIOMERIEUX SA 1007539480

    Patients

    Seq Age Sex Outcome Treatment
    1