BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TSH ASSAY

    MDR report key: 7665251 · Received July 5, 2018

    Report

    Report Number
    3002769706-2018-00096
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Report Date
    November 27, 2018
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    KLI
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF A FALSELY OVER-ESTIMATED RESULT ASSOCIATED WITH VIDAS® TSH (REFERENCE 30400). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER SAMPLES WERE NOT AVAILABLE TO SUBMIT AS PART OF THE INVESTIGATION. QUALITY CONTROL RECORDS WERE REVIEWED: - 30400 VIDAS TSH BATCH 1006065870/181024-0 : NO OTHER SIMILAR COMPLAINT REGISTERED ON THIS BATCH. - NO CAPA NOR NON-CONFORMITY LINKED TO THE CUSTOMER'S ISSUE. - NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS: - FIVE (5) INTERNAL SERA - FIVE (5) LOTS INCLUDING CUSTOMER'S LOT NUMBER 181024-0 AND FOUR (4) OTHER LOTS (181006-0 ; 181017-0 ; 181107-0 AND 181113-0). => ALL RESULTS ARE WITHIN SPECIFICATIONS, AND CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED IN COMPLAINTS LABORATORY, MARCY : => FIVE (5) INTERNAL SERA WERE TESTED, AND ALL RESULTS WERE WITHIN EXPECTED SPECIFICATION / NO EVOLUTION SINCE BATCH RELEASE. VIDAS TSH 181024-0 (TEST RESULTS IN HOUSE KIT) (B)(4). ** CONCLUSION ** - ALL INTERNAL SERA TESTED WERE FOUND WITHIN EXPECTED SPECIFICATION FOR THIS LOT OF VIDAS TSH BATCH 1006065870/181024-0 COMPARED TO FOUR (4) OTHER BATCHES, WITH NO EVOLUTION SINCE BATCH RELEASE. THE CUSTOMERS' ANOMALY WAS NOT REPRODUCED INTERNALLY. - NO PATIENT SAMPLE WAS RETURNED FROM THE CUSTOMER SITE, SO IT'S IMPOSSIBLE TO PURSUE FURTHER INVESTIGATIONS. - AS INDICATED IN THE VIDAS TSH PACKAGE INSERT, EN, PAGE 5, CHAPTER: "RESULTS AND INTERPRETATION": "INTERPRETATION OF TEST RESULTS SHOULD BE MADE TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. AND CHAPTER : "LIMITATIONS OF THE METHOD" : "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. THE RESULTS OF A TSH ASSAY MUST BE INTERPRETED AS PART OF A COMPLETE CLINICAL PROFILE. IN CASE OF DISCREPANCY, THIS ASSESSMENT MUST BE COMPLETED BY THYROID HORMONE MEASUREMENT." PERFORMANCE OF VIDAS TSH BATCH 1006065870/181024-0 IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSELY OVER-ESTIMATED RESULT ASSOCIATED WITH VIDAS® TSH (REFERENCE 30400). THE CUSTOMER REPORTED THAT THE VALUES ASSOCIATED WITH VIDAS® TSH WERE REPORTED ON THE HIGHER SIDE SO THE PHYSICIAN QUESTIONED THE RESULTS BECAUSE THE RESULT WAS NOT CORRELATING WITH THE PATIENT CLINICAL CONDITION. THE RESULT WAS ALSO CROSS-CHECKED WITH THE A DIFFERENT METHOD (ECLIA) ON AN ABBOTT INSTRUMENT AND THE RESULT WAS WITHIN NORMAL RANGE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506115 VIDAS® TSH ASSAY VIDAS® TSH ASSAY KLI BIOMERIEUX, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1