BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDAS® TOXO IGG II

    MDR report key: 5795347 · Received July 14, 2016

    Report

    Report Number
    3002769706-2016-00117
    Event Type
    Death
    Date Received
    July 14, 2016
    Report Date
    June 27, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED DISCREPANT AVIDITY RESULTS IN ASSOCIATION WITH THE VIDAS TOXO IGG (TXG) II ASSAY. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ISSUE CAN OCCUR WHEN IT IS NECESSARY TO BRING THE SAMPLE TITER TO 15 UI/ML, AS STATED IN PACKAGE INSERT OF VIDAS TOXO IGG AVIDITY. EVALUATION OF THE MANUFACTURING BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ANOMALY OR NONCONFORMITY ASSOCIATED WITH THE BATCH. INTERNAL TESTING DEMONSTRATED THAT: THERE IS NO ISSUE WITH THE SENSITIVITY NOR THE SPECIFICITY OF THE TEST. THE VIDAS TOXO IGG II IS WITHIN THE EXPECTED PERFORMANCE CLAIMED IN THE PACKAGE INSERT. IN THE VIDAS TOXO IGG II APPLICATION, SOME HIGH TITER SAMPLES MAY BE UNDERESTIMATED WHEN DILUTED BUT THERE IS NO RISK OF FALSE NEGATIVE RESULTS. IN THE VIDAS TOXO IGG AVIDITY APPLICATION, THE VIDAS SYSTEM WILL DISPLAY "INVALID RESULTS" IF THE SAMPLE DILUTION IS NOT OPTIMAL, BUT THERE IS NO RISK OF FALSE AVIDITY RESULTS. THE INVESTIGATION CONCLUDED THE PERFORMANCE OF VIDAS TXG II ASSAY IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX REGARDING DISCREPANT RESULTS WITH THE VIDAS TOXO IGG II TEST KIT (REFERENCE 30210) THE CUSTOMER REPORTS THAT TWO SAMPLES WERE PREVIOUSLY TESTED BY A LABORATORY WHERE THE PURE SAMPLE WAS TESTED AT DILUTIONS OF 1/5 AND 1/10; THESE RESULTS, PER THE CUSTOMER, DEMONSTRATED THAT THE PERFORMANCE DID NOT PRODUCE AN ACCEPTABLE LEVEL OF LINEARITY. THE CUSTOMER REPORTS TESTING PREVIOUS SAMPLES ON A NEW BATCH OF PRODUCT USING A NEW VIDASINSTRUMENT; THIS TESTING RESULTED IN A CONFIRMATION OF THE PREVIOUS NON-LINEAR RESULTS. IN THIS INCIDENT, THE CUSTOMER REPORTED THE DEATH OF A PATIENT RELATED TO CONGENITAL TOXOPLASMOSIS; HOWEVER, THE PHYSICIAN INDICATED THE DEATH WAS NOT RELATED TO RESULTS OBTAINED BY THE VIDASOXO IGG II, BUT INSTEAD RELATED TO UNDERLYING PROBLEMS THE PATIENT HAD. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447316 VIDAS® TOXO IGG II VIDAS® TOXO IGG II CHP BIOMERIEUX SA 1004465080

    Patients

    Seq Age Sex Outcome Treatment
    1 Death