BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS TOXO IGG II 60 TESTS

    MDR report key: 11087715 · Received December 29, 2020

    Report

    Report Number
    8020790-2020-00143
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A COLOMBIAN CUSTOMER NOTIFIED BIOMÉRIEUX OF OBTAINING POSITIVE RESULTS WHEN TESTING PATIENTS' SAMPLES ON VIDAS TOXO IGG (REF. (B)(4); LOT# 1008007940 / 210222-0) WHILE THEY GAVE A NEGATIVE RESULT WITH A CHEMILUMINESCENCE METHOD (ARCHITECT ABBOTT). THESE SAMPLES WERE TESTED ON A MINIVIDAS INSTRUMENT ONLY FOR IGG ANTI-TOXOPLASMOSIS SEROLOGY (NO AVAILABLE RESULTS AVAILABLE FOR IGM). INVESTIGATION THE INVESTIGATION REVIEWED PRODUCTION AND QUALITY CONTROL RECORDS FOR THE CUSTOMER¿S LOT. NO ANOMALIES DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON VIDAS TOXO IGG II LOT 1008007940 / 210222-0 WERE HIGHLIGHTED. ADDITIONALLY, NO CAPA NOR NON-CONFORMITY WAS RECORDED ON THIS VIDAS ASSAY IN LINK WITH THE CUSTOMER'S ISSUE. TESTING COMPLAINTS LABORATORY PERFORMED A CONTROL CHART ANALYSIS FOR EIGHT INTERNAL SAMPLES (4 SAMPLES WITH A NEGATIVE TARGET, 2 SAMPLES WITH A TARGET ON THE POSITIVE CUT-OFF, 2 SAMPLES WITH A POSITIVE TARGET) ON SEVEN VIDAS TOXO IGG II BATCHES INCLUDING RETAINED SAMPLES OF THE LOT MENTIONED BY CUSTOMER - 1008007940 / 210222-0. THE ANALYSIS SHOWED THAT THE SAMPLES COMPLY WITH THE EXPECTATIONS AND VIDAS TOXO IGG II BATCH 1008007940 / 210222-0 IS IN THE TREND COMPARED TO THE OTHER LOTS. THE INVESTIGATOR TESTED FOUR INTERNAL SAMPLES (2 WITH A NEGATIVE TARGET AND 1 WITH A TARGET WITHIN THE EQUIVOCAL ZONE AND 1 WITH A POSITIVE TARGET) ON THE RETAINED KITS FROM THE CUSTOMER LOT. THE RESULTS COMPLIED WITH EXPECTATIONS, AND PERFORMANCE OF THE CUSTOMER¿S LOT WAS CONSISTENT AS COMPARED TO OTHER LOTS. THEY DID NOT OBSERVE ANY EVOLUTION OVER TIME OF VIDAS TOXO IGG II BATCH 1008007940 / 210222-0. THE COMPLAINTS LABORATORY DID NOT REPRODUCE ANY UNEXPECTED POSITIVE RESULT WITH THE INTERNAL SAMPLE. THE CUSTOMER REPORTED THAT NONE OF THE PATIENTS¿ SAMPLES WERE AVAILABLE TO SUBMIT FOR FURTHER EVALUATION. WITHOUT THE CONCERNED SAMPLES, FURTHER INVESTIGATION CANNOT BE PURSUED. THE VIDAS TOXO IGG II REF. (B)(4) PACKAGE INSERT CONTAINS THE FOLLOWING TEXT: ¿LIMITATIONS OF THE METHOD: ¿POSITIVE TEST RESULTS FROM CORD BLOOD SHOULD BE INTERPRETED WITH CAUTION. THE PRESENCE OF TOTAL OR IGG ANTI-T. GONDII ANTIBODIES IN CORD BLOOD IS USUALLY THE RESULT OF PASSIVE TRANSFER FROM THE MOTHER TO THE FETUS. POSITIVE TEST RESULTS MAY NOT BE VALID IN PERSONS WHO HAVE RECEIVED BLOOD TRANSFUSIONS OR OTHER BLOOD PRODUCTS WITHIN THE PAST SEVERAL MONTHS. VIDAS TOXO IGG II RESULTS SHOULD BE USED IN CONJUNCTION WITH CLINICAL SYMPTOMS AND LABORATORY TEST RESULTS, SUCH AS ANTI-T. GONDII IGM RESULTS. THE VIDAS TOXO IGG II ASSAY MAY ONLY BE USED WITH SERUM OR PLASMA (EDTA, HEPARIN) SAMPLES. THE USE OF AMNIOTIC FLUID OR OTHER BODY FLUIDS HAS NOT BEEN ESTABLISHED. 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'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED.¿ CONCLUSION THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER ISSUE. REVIEW OF LOT HISTORY DID NOT SHOW ANY ANOMALIES AND THE LOT MET FINAL RELEASE CRITERIA. RETAINED KITS PERFORMED AS EXPECTED; ALSO NOT DISPLAYING ANY DISCREPANCIES. WITHOUT SUBMISSION OF THE PATIENT SAMPLE, THE INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER¿S ISSUE.

    Description of Event or Problem · 1

    NOTE: REFERENCE 30210 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30210-01. A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH VIDAS® TOXO IGG II 60 TESTS (REF 30210, BATCH 1007488980) WHEN TESTING THREE SAMPLES FROM SEPARATE PATIENTS. THE CUSTOMER STATED THAT THEY OBTAINED DISCREPANT RESULTS WHILE TESTING PATIENT SAMPLES ON MINIVIDAS® AND WITH CHEMILUMINESCENCE (METHOD NOT REPORTED). THE RESULTS FOR BOTH TEST METHODS ARE LISTED BELOW. SAMPLE 1: VIDAS® TOXO IGG RESULT = 9 UI/ML (POSITIVE INTERPRETATION) CHEMILUMINESCENCE RESULT = 1.2 UI/ML (NEGATIVE INTERPRETATION) THE CUSTOMER CONFIRMED THE CALIBRATION AND CONTROLS PROCESSED ON THEIR MINIVIDAS® INSTRUMENT WERE WITHIN RANGE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE POSITIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551335 VIDAS TOXO IGG II 60 TESTS VIDAS® TOXO IGG II 60 TESTS LGD BIOMERIEUX SA 1007488980

    Patients

    Seq Age Sex Outcome Treatment
    1