BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TSH 60 TESTS

    MDR report key: 9862863 · Received March 20, 2020

    Report

    Report Number
    8020790-2020-00034
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Report Date
    May 7, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LYR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF OBTAINING FALSELY UNDERESTIMATED RESULTS FOR TWO SAMPLES FROM ONE PATIENT IN ASSOCIATION WITH VIDAS® TSH TEST KIT (REF 30400, LOT 1007567330). TWO SAMPLES WERE SUBMITTED BY THE CUSTOMER FOR THE INVESTIGATION. THE COMPLAINT LABORATORY PERFORMED TESTING ON INTERNAL SAMPLES AS WELL AS THE CUSTOMER'S SAMPLES WITH MULTIPLE LOTS INCLUDING THE CUSTOMER'S LOT. ALL TEST RESULTS FROM INTERNAL SAMPLES WERE WITHIN SPECIFICATION AND DID NOT INDICATE AN ISSUE WITH THE PRODUCT. TESTING THE CUSTOMER'S SAMPLES REPRODUCED THE CUSTOMER'S ISSUE FOR ONE SAMPLE, BUT NOT FOR THE SECOND SAMPLE. THE INVESTIGATION CONCLUDED THAT THE CAUSE FOR THE FALSELY UNDERESTIMATED RESULTS WAS NOT RELATED TO A SPECIFIC LOT OF PRODUCT, BUT RATHER AN INTERFERENCE PRESENT IN THE PATIENT SAMPLE. NO FURTHER INVESTIGATION INTO THE SOURCE OF THE INTERFERENCE COULD BE COMPLETED AS THERE WAS NOT ENOUGH SAMPLE FOR ADDITIONAL TESTING. SEE H10 FOR ADDTL MFG NARRATIVE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSELY UNDERESTIMATED RESULTS FOR TWO SAMPLES FROM ONE PATIENT IN ASSOCIATION WITH VIDAS® TSH TEST KIT (REF 30400, LOT 1007567330). THE CUSTOMER STATED BOTH SAMPLES WERE TESTED USING THE VIDAS® TSH TEST KIT AND OBTAINED RESULTS OF 0.07UUI AND 0.08UUI. THE ROCHE TEST METHOD AT AN EXTERNAL LABORATORY OBTAINED A RESULT OF 1.79MIU. 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. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324081 VIDAS® TSH 60 TESTS VIDAS® TSH 60 TESTS LYR BIOMERIEUX SA 1007567330

    Patients

    Seq Age Sex Outcome Treatment
    1