BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TSH3 ASSAY

    MDR report key: 9142194 · Received October 1, 2019

    Report

    Report Number
    8020790-2019-00057
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JLW
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF A FALSE LOW RESULT IN ASSOCIATION WITH THE VIDAS® TSH3 ASSAY (REFERENCE 30441, LOT 1006905220). THE CUSTOMER'S SAMPLE WAS NOT AVAILABLE TO SUBMIT FOR THE INVESTIGATION. THE INVESTIGATION INCLUDED A TREND ANALYSIS, A REVIEW OF QUALITY CONTROL RECORDS, A STUDY OF CONTROL CHARTS FOR INTERNAL SAMPLES, AND TESTING OF INTERNAL SAMPLES WITH RETAINED KITS OF THE CUSTOMER'S IMPACTED LOT. ADDITIONALLY, THE CUSTOMER PROVIDED FURTHER TESTING DATA ON THE SAMPLE. INVESTIGATION RESULTS: COMPLAINT TRENDING ANALYSIS: THE TREND ANALYSIS SHOWED NO RECURRENCE OF THE CUSTOMER'S ANOMALY. QUALITY CONTROL RECORDS: THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO NON-CONFORMITY AND NO CAPA WAS LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS TSH3 (REF 30441). STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT: ON THREE INTERNAL HYPOTHYROIDISM SERA WITH DIFFERENT CONCENTRATIONS (TARGET: 7.02 UI/ML, 14.6 UI/ML, AND 25.6 UI/ML). ON SEVEN VIDAS TSH3 BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER (1006905220/191021-0). ALL THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS TSH3 LOT 1006905220/191021-0 WAS IN THE TREND COMPARED TO THE OTHER BATCHES. TEST PERFORMED BY COMPLAINT LABORATORY: THE INTERNAL LABORATORY PERFORMED A CALIBRATION WITH THREE INTERNAL HYPOTHYROIDISM TSH SERUMS ON THE RETAINED KIT VIDAS TSH3 LOT 1006905220/191021-0: ALL RESULTS WERE WITHIN THEIR SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED DURING THE PROCESS OF CONTROL OF THE LOT. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE. TESTS PERFORMED BY THE CUSTOMER: TEST PERFORMED BY THE CUSTOMER ON HBT TUBE (HETEROPHILIC BLOCKING TUBE) GAVE HIGHER RESULTS IN VIDAS TSH3 (9.253 UI / ML) AND ALSO IN VITROS (13 UI/ML). RESULTS SHOWED THAT THERE WAS AN INTERFERENCE DUE TO HETEROPHILIC ANTIBODIES. CONCLUSION: ACCORDING TO ALL INFORMATION ABOVE, THE MAIN PROBABLE ROOT CAUSE TO CUSTOMER'S ISSUE IS AN INTERFERENCE DUE TO HETEROPHILIC ANTIBODIES PRESENT IN THE PATIENT SAMPLE. THESE INTERFERENCES ARE RARE IN VIDAS TSH3 BUT CAN BE ENCOUNTERED SOMETIMES AS INDICATED IN THE PACKAGE INSERT OF VIDAS TSH3: LIMITATIONS OF THE METHOD: INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. THE RESULTS OF A TSH3 ASSAY MUST BE INTERPRETED AS PART OF A COMPLETE CLINICAL PROFILE. IN CASE OF DISCREPANCY, THIS ASSESSMENT MUST BE COMPLETED BY THYROID HORMONE MEASUREMENT. THE INVESTIGATION CONCLUDED THAT VIDAS TSH3 REF. 30441, LOT 1006905220 / 191021-0, IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE LOW RESULT IN ASSOCIATION WITH THE VIDAS® TSH3 ASSAY (REFERENCE 30441, LOT 1006905220). THE CUSTOMER STATED THEY OBTAINED A RESULT OF 1.93 UIU/ ML (NORMAL RANGE 0.27-4.70). THE CUSTOMER ALSO TESTED THE SAMPLE USING VITROS® YIELDING A RESULT OF 7.96 UIU/ ML (NORMAL RANGE 0.465 - 4.68) AND COBAS ® YIELDING A RESULT OF 8.82 UIU/ M (NORMAL RANGE 0.270 - 4.20). THOUGH VIDAS® TSH3 ASSAY (REFERENCE 30441) IS NOT REGISTERED, MARKETED OR DISTRIBUTED IN THE U.S., A SIMILAR PRODUCT VIDAS® TSH (REFERENCE 30400-01) IS REGISTERED IN THE U.S. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THIS INCIDENT HAVE 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
    935033 VIDAS® TSH3 ASSAY VIDAS® TSH3 ASSAY JLW BIOMERIEUX SA 30441

    Patients

    Seq Age Sex Outcome Treatment
    1