BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6637080 · Received June 13, 2017

    Report

    Report Number
    3002769706-2017-00136
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Report Date
    July 25, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    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

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR EXTERNAL QUALITY CONTROLS ((B)(4) ASSOCIATED WITH VIDAS® TOXO IGM (REFERENCE (B)(4)). AN INVESTIGATION WAS PERFORMED. THE REPORT FROM (B)(4) WAS REVIEWED, WHEREAS, (B)(4) TOXO 171 - SAMPLE 1712, WAS FOUND NEGATIVE BY A MAJORITY OF VIDAS® PARTICIPANTS WHEN IT WAS EXPECTED TO BE POSITIVE WITH VIDAS® TOXO IGM. RESULTS FOR (B)(4) TOXO 171 - SAMPLE 1712 WERE AS FOLLOWS : 2 PARTICIPANTS GAVE A POSITIVE RESULT AS EXPECTED, 18 PARTICIPANTS GAVE AN EQUIVOCAL RESULT, 81 PARTICIPANTS GAVE A NEGATIVE RESULT. A REVIEW OF QUALITY RECORDS CONFIRMED THE MANUFACTURING OF VIDAS® TOXO IGM LOTS 170608-0 / 171213-0 / 180213-0 AND 170718-0 WERE WITHIN SPECIFICATION. THE (B)(4) TOXO 171 SAMPLE 1712 WAS TESTED AND THE RESULT WAS POSITIVE ON VIDAS® TOXO IGM LOTS 170608-0, 171213-0 AND 180213-0. A COMPLEMENTARY AVIDITY TEST WAS PERFORMED FOR THE EXTERNAL QUALITY CONTROL (B)(4) TOXO 171 SAMPLE 1712, AND GAVE A HIGH AVIDITY RESULT. ACCORDING TO THE PACKAGE INSERT, A RESULT OF AVIDITY HIGHER THAN 0.300 INDICATES AN OLD INFECTION, OLDER THAN 4 MONTHS. THE CONCLUSION OF A PROBABLE OLD INFECTION IS COHERENT WITH THE AGE OF PREGNANCY INDICATED IN (B)(4) REPORT (14 WEEKS). HYPOTHETIS : EQA (B)(4) 171 SAMPLE 1712 CONTAINS RESIDUAL IGM WHICH ARE NOT DETECTED BY VIDAS® TECHNIQUE. VIDAS® TOXO IGM DETECTS IGM FOR A SHORTER PERIOD OF TIME THAN OTHER COMPETITORS. IT IS ACCEPTABLE TO OBTAIN A DOUBTFUL RESULT IN A CONTEXT OF OLD INFECTION, ESPECIALLY MORE SO WHEN THE SENSITIVITY IS HIGHER THAN 90% IN THE CONTEXT OF A RECENT INFECTION (CNR PUBLICATION - J. CLIN. MICROBIOL.-2016-VILLARD-3034-42) . THE EXTERNAL QUALITY CONTROL (B)(4) TOXO 171 SAMPLE 1712 IS COMPOSED OF HUMAN MATRIX. EQA ARE MANUFACTURED AND CANNOT BE CONSIDERED AS NATURAL SAMPLES FROM PATIENT. IN CONCLUSION, THERE IS NO PERFORMANCE ISSUE AND VIDAS® TOXO IGM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY OBSERVED A FALSE NEGATIVE RESULT FOR AN EXTERNAL QUALITY CONTROL SAMPLE IN ASSOCIATION WITH VIDAS® TOXO IGM. THE CUSTOMER PERFORMED THE QUALITY CONTROL TEST AS PART OF EEQ CTCB 171. THE RESULT (311 RFT VT AT 0.51) WAS NEGATIVE WHEN EXPECTED POSITIVE. THE EEQ CTCB 171 PEER TEST GROUP CONSISTING OF 100 TESTS IN VIDAS® HAD ONLY TWO POSITIVE RESULTS IN WHICH ONE WAS THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418189 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX, S.A. 1005198640

    Patients

    Seq Age Sex Outcome Treatment
    1