BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG II

    MDR report key: 8409152 · Received March 11, 2019

    Report

    Report Number
    8020790-2019-00018
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 1, 2019
    Report Date
    May 17, 2019
    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 INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE POSITIVE RESULT IN ASSOCIATION WITH THE VIDAS® TOXO IGG II ASSAY. THE CUSTOMER SUBMITTED THE ISOLATE FOR EVALUATION. A REVIEW OF QUALITY RECORDS CONFIRMED: NO OTHER SIMILAR COMPLAINT WAS RECORDED ON VIDAS TOXO IGG II, LOT 1006882010/190913-0. NO CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) NOR NON-CONFORMITY LINKED TO THE CUSTOMER'S COMPLAINT WAS RECORDED ON VIDAS TOXO IGG II, REF 30210. ANALYSIS OF THE BATCH HISTORY RECORD SHOWS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. A STUDY OF INTERNAL SAMPLE CONTROL CHARTS OF THREE INTERNAL NEGATIVE SAMPLES AND ONE INTERNAL POSITIVE SAMPLE WERE OBSERVED ON SIX DIFFERENT LOTS OF VIDAS TOXO IGG II INCLUDING THE CUSTOMER'S LOT. THE RESULTS OBSERVED WERE WITHIN THE EXPECTED SPECIFICATIONS. VIDAS TOXO IGG II, LOT 1006882010/190913-0. WAS IN THE TREND OF THE OTHER LOTS. TESTING OF INTERNAL SAMPLES: FOUR INTERNAL SAMPLES WERE TESTED ON VIDAS TOXO IGG II, LOT 1006882010/190913-0, AND ALL THE RESULTS CONFORMED TO EXPECTED SPECIFICATIONS. THE RESULTS WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCHES' RELEASE. THERE WAS NO DRIFT OF THE LOTS SINCE THE BATCHES' RELEASE. TESTING OF CUSTOMER'S SAMPLE (B)(6): VIDAS TOXO IGG II, LOT 1006882010/190913-0 : 7UI/ML (EQUIVOCAL) INTERFERENCE RESEARCH: WAALER ROSE SLIDE TEST WAS A LOW LEVEL RESULT WITH THE PRESENCE OF RHEUMATOID FACTOR (LOW LEVEL). EXTERNAL TOXOPLASMOSIS EXPERT ASSESSMENT ON PATIENT'S RETURN SAMPLE (30425540): TOXO IGG (OTHER EIA) NEGATIVE. TOXO IGM (OTHER EIA) NEGATIVE. VIDAS TOXO IGG II: 4 UI/ML EQUIVOCAL. VIDAS TOXO IGM : NEGATIVE. WESTERN BLOT IGG : TOXO II IGG, LDBIO DIAGNOSTICS WESTERN BLOT LGGII ANTI-T. GONDII : ABSENCE OF SPECIFIC BAND. (4 NON-SPECIFIC WEAK BANDS). CONCLUSION: THE CUSTOMER'S PATIENT SAMPLE WAS POSITIVE, 8IU/ML WITH VIDAS TOXO IGG II, LOT 1006882010/190913-0. INTERNALLY, 7 IU/ML (EQUIVOCAL RESULT) WAS OBTAINED WITH THE SAME LOT NUMBER. ADDITIONAL TESTS REVEALED THE PRESENCE OF RHEUMATOID FACTOR WITH A LOW POSITIVE RESULT . EXTERNAL EXPERTISE CONCLUSION: "EQUIVOCAL IGG LEVEL WITH ELISA-VIDAS AND NEGATIVE BY ELISA-ARCHITECT. ABSENCE OF SPECIFIC BANDS WITH WESTERN BLOT IGG II WHICH IS THE CONFIRMATION METHOD(THRESHOLD: 3 SPECIFIC BANDS). WE CAN NOTICE THE PRESENCE OF 4 NON-SPECIFIC WEAK BANDS THAT CAN BE EXPLAINED THE VERY LOW LEVEL OBTAINED IN ELISA - VIDAS. BASED ON THESE RESULTS, THIS PATIENT SHOULD BE CONSIDERED AS NON-IMMUNIZED. " ACCORDING TO THE PACKAGE INSERT, LIMITATIONS OF THE METHOD, (7). : " INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED." ACCORDING TO THE INFORMATION ABOVE, VIDAS TOXO IGG II, 1006882010/190913-0 IS STILL WITHIN ITS EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT IN ASSOCIATION WITH THE VIDAS® TOXO IGG II ASSAY. THE CUSTOMER STATED THE PATIENT IS BEING MONITORED DURING PREGNANCY. VIDAS TOXO IGG II RESULTS FROM (B)(6) 2019 ARE AS FOLLOWS: VIDAS TXGII LOT 190913-0: 649 RFV / 8 IU / ML => POSITIVE; VIDAS TXM LOT 190903-0: 40 RFV / 0.05 VT => NEGATIVE; RETEST VIDAS TXGII LOT 190913-0: 652 RFV / 8 IU / ML => POSITIVE. BIOMÉRIEUX REQUESTED PATIENT STRAIN SUBMITTAL FOR INVESTIGATION. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203786 VIDAS® TOXO IGG II VIDAS® TOXO IGG II LGD BIOMERIEUX SA 1006882010

    Patients

    Seq Age Sex Outcome Treatment
    1