BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG AVIDITY

    MDR report key: 8362051 · Received February 22, 2019

    Report

    Report Number
    8020790-2019-00015
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    October 25, 2018
    Report Date
    June 8, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K101946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE HIGH AVIDITY RESULT WHEN USING LOT 1006358520 OF THE VIDAS® TOXO IGG AVIDITY (TXGA) ASSAY. THE CUSTOMER USED VIDAS TXGA BATCHES 1006358520/ 190210-0 AND 1006568420/ 190421-0. THE CUSTOMER'S REFERENCE LABORATORY USED VIDAS TXGA BATCHES 1006568420/ 190421-0 AND 1006823520/ 190718-0. THE CUSTOMER DID NOT SUBMIT THE SAMPLES FOR EVALUATION. A REVIEW OF QUALITY RECORDS CONFIRMED THERE WAS NO OTHER COMPLAINT ON THE CUSTOMER LOTS OF VIDAS TXGA, AND NO CAPA OR NONCONFORMITY RELATED TO THIS ISSUE. THE ANALYSIS OF VIDAS TXGA BATCH HISTORY RECORDS FOR THE BATCHES USED BY THE CUSTOMER (1006358520/190210-0 AND 1006568420/190421-0) SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. A STUDY OF THE INTERNAL SAMPLES CONTROL CHARTS ON FOUR INTERNAL SERA WITH HIGH AND INTERMEDIATE AVIDITIES FOR BATCHES 1006358520/190210-0,1006568420/190421-0, AND THREE OTHER BATCHES, SHOWED ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND 1006358520/190210-0 AND BATCH 1006568420/190421-0 ARE IN THE TREND OF THE OTHER LOTS. INTERNAL TESTING WAS PERFORMED WITH THREE INTERNAL SERA WITH HIGH AVIDITY INTERPRETATION, AND ONE INTERNAL SERA WITH INTERMEDIATE INTERPRETATION. THEY WERE TESTED ON THE RETAINED KIT VIDAS TXGA LOT 1006568420/190421-0. THE BATCH 1006358520/190210-0 COULD NOT BE USED BECAUSE IT WAS EXPIRED WHEN PERFORMING THE INVESTIGATION. ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED BEFORE THE BATCH RELEASE. THERE WAS NO EVOLUTION OBSERVED OF VIDAS TXGA BATCH 1006568420/190421-0 AN ADDITIONAL TEST WAS CARRIED OUT ON THE SAME INTERNAL SAMPLES WITH DIFFERENT DILUTION FACTORS, TO DETERMINE IF AN INAPPROPRIATE DILUTION LEADING TO AN IGG ANTI TOXOPLASMA CONCENTRATION LOWER THAN 15 UI/ML, COULD HAVE AN IMPACT ON THE AVIDITY RESULTS AND INTERPRETATION. THE FOUR INTERNAL SAMPLES MENTIONED ABOVE WERE TESTED WITH THE APPROPRIATE DILUTION AND HIGHER DILUTIONS ON VIDAS TXGA 1006568420/190421-0 AND1006723520/190718-0 (1ST BATCH USED IN THE CUSTOMER'S LABORATORY AND IN THE REFERENCE LABORATORY AND THE SECOND ONE USED ONLY IN THE REFERENCE LABORATORY). ALL THE RESULTS OBTAINED WERE SIMILAR WHATEVER THE BATCH AND DILUTION USED . THE CUSTOMER'S ISSUE WAS NOT REPRODUCED ON INTERNAL SAMPLES. CONCLUSION: THE CUSTOMER'S SAMPLES WERE NOT RECEIVED FOR INVESTIGATION, SO IT WAS NOT POSSIBLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE VIDAS TOXO IGG AVIDITY RESULTS. THE ISSUE COULD BE LINKED TO THE PATIENTS (SUCH AS A SPECIFIC CLINICAL HISTORY) OR THE SAMPLES THEMSELVES (SUCH AS STABILITY OR INTERFERENCES). AS INDICATED IN THE PACKAGE INSERT - LIMITATIONS OF THE METHOD : "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST THE REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY AND THE RESULTS OF ANY OTHER TESTS PERFORMED." ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS TOXO IGG AVIDITY BATCHES 1006358520/190210-0 AND 006568420/190421-0 PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE HIGH AVIDITY RESULT WHEN USING LOT 1006358520 OF THE VIDAS® TOXO IGG AVIDITY ASSAY. THE CUSTOMER REPORTED THAT THEIR RESULT AND THE REFERENCE LAB RESULT WERE DIFFERENT. FIRST RESULT: AVIDITY - 0.41 HIGH AVIDITY, SECOND RESULT: 0.093 LOW AVIDITY, VIDAS IGG RESULT - 2540, VIDAS PC INSTRUMENT, DATE: (B)(6) 2018. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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
    155183 VIDAS® TOXO IGG AVIDITY VIDAS® TOXO IGG AVIDITY LGD BIOMERIEUX SA 1006358520

    Patients

    Seq Age Sex Outcome Treatment
    1