BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6296505 · Received February 2, 2017

    Report

    Report Number
    3002769706-2017-00016
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Report Date
    February 6, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED USING THE INTERNAL EAQ STRAIN. THE INVESTIGATION CONCLUSION FOLLOWS: THE EAQ CTCB 1622 SURVEY SUMMARY REPORT INDICATES THAT LABORATORIES USING VIDAS® TOXO IGG FOR SAMPLE TESTING ACHIEVED THE FOLLOWING RESULTS: - 74 PARTICIPANTS GAVE A POSITIVE RESULT AS EXPECTED, - 33 PARTICIPANTS GAVE AN EQUIVOCAL RESULT, - 3 PARTICIPANTS GAVE A NEGATIVE RESULT. EVALUATION OF THE BATCH HISTORY RECORD FOR VIDAS® TOXO IGM LOTS 1005081940 / 170530-0 (BATCH NUMBER GIVEN BY ONE CUSTOMER), 1004792810 / 170129-0 AND 1005198640 / 170718-0 (2 LOTS SELECTED ARBITRARILY BY QUALITY PRODUCT LABORATORY) SHOW NO ANOMALY DURING THE CONTROL PROCESS. THE QUALITY PRODUCT LABORATORY ANALYZED CONTROL CHARTS FOR FIVE (5) INTERNAL SAMPLES (ONE NEGATIVE SAMPLE AND FOUR POSITIVE SAMPLES) FROM QUALITY CONTROL DEPARTMENT FOR NINE (9) LOTS OF VIDAS® TOXO IGM INCLUDING LOTS 170530-0, 170129-0 AND 170718-0; ALL THE RESULTS ARE WITHIN EXPECTED RANGES AND ALL BATCHES ARE WITHIN THE TREND OF THE PARAMETER. QUALITY PRODUCT DEPARTMENT TESTED FOUR (4) INTERNAL SAMPLES (ONE NEGATIVE SAMPLE AND 3 POSITIVE SAMPLES) WITH THESE THREE (3) VIDAS® TOXO IGM BATCHES; ALL RESULTS WERE WITHIN EXPECTED RANGES AND ALL BATCHES WERE WITHIN THE TREND OF THE PARAMETER. QUALITY PRODUCT DEPARTMENT TESTED THE CONTROL CTCB TOXO 1622 AND FOUND A POSITIVE RESULT ON THREE (3) BATCHES VIDAS TOXO IGM: LOTS 170530-0 (QP RESULT 0.66VT), 170129-0 (QP RESULT 0.66VT) AND 170718-0 (QP RESULT 0.68VT). QUALITY PRODUCT DEPARTMENT CONFIRMED THE POSITIVE EXPECTED RESULTS INDICATED BY CTCB AND DID NOT REPRODUCE NEGATIVE RESULT OBTAINED BY CUSTOMER. THE INVESTIGATION CONCLUDED VIDAS® TOXO IGM LOT 1005081940 IS PERFORMING WITHIN THE EXPECTED PERFORMANCE CRITERIA. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE NEGATIVE RESULT (0.53) FOR AN EXTERNAL QUALITY SURVEY SAMPLE (EAQ CTCB 1622) IN ASSOCIATION WITH THE VIDAS® TOXO IGM ASSAY. THE EXPECTED RESULT WAS POSITIVE (TARGET VALUE 0.65). VIDAS® TOXO IGM REFERENCE 30202 IS NOT SOLD IN THE UNITED STATES; HOWEVER, A SIMILAR PRODUCT VIDAS® TOXO IGM REFERENCE 30202-01 IS SOLD IN THE UNITED STATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE EAQ SURVEY SAMPLE. AS THE BIOMÉRIEUX QUALITY LAB IS ENROLLED IN THIS EAQ TESTING, AN INTERNAL INVESTIGATION HAS BEEN CONDUCTED USING THE INTERNAL STRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80897 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX SA 1005081940

    Patients

    Seq Age Sex Outcome Treatment
    1