BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 5960978 · Received September 19, 2016

    Report

    Report Number
    3002769706-2016-00342
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Report Date
    August 22, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE RESULT FOR A (B)(6) IN ASSOCIATION WITH THE VIDAS® 3 MEASLES IGG ASSAY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. SPECIMEN (B)(6) MEASLES AND MUMPS IGG SEROLOGY DISTRIBUTION (B)(6) GAVE AN UNEXPECTED POSITIVE RESULT FOR SOME LABORATORIES WITH VIDAS® MEASLES IGG. ON THE (B)(6) REPORT, IT IS MENTIONED THAT : THE SPECIMEN (B)(6) WAS EXPECTED TO BE NEGATIVE FOR MSG (TESTED NEGATIVE WITH SIEMENS ENZYGNOST 1 MIU/ML). ONE HUNDRED THIRTY SIX PARTICIPANTS, GAVE THE EXPECTED RESULT NEGATIVE. TWENTY FIVE PARTICIPANTS GAVE AN EQUIVOCAL RESULT (24 PARTICIPANTS USING VIDAS MSG). EIGHTEEN PARTICIPANTS GAVE A POSITIVE RESULT (15 PARTICIPANTS USING VIDAS MSG). IN PRE-DISTRIBUTION TESTING, THE MEASLES IGG RESULTS WERE NEGATIVE WITH TRINITY BIOTECH, CAPTIA, SIEMENS ENZYGNOST, DIASORIN LIAISON ASSAYS WHILE IT WAS EQUIVOCAL WITH BIOMÉRIEUX VIDAS®. THE BIOMÉRIEUX LAB TESTED SPECIMEN (B)(6) AND FOUND AN EQUIVOCAL RESULT WITH BATCH 1004566030 / 161110-0 AND A POSITIVE RESULT WITH BATCH 1004457540 / 160929-0. ADDITIONAL TESTING WAS DONE ON FOUR (4) INTERNAL SERA (2 NEGATIVE AND 2 POSITIVE) ON THE RETAINS KIT VIDAS® MSG 1004457540 / 160929-0 AND 1004566030 / 161110-0 : THE RESULTS DID NOT CHANGE IN TERM OF SEROLOGICAL INTERPRETATION SINCE THE ACTIVITY RESULTS OBTAINED BY THE QUALITY CONTROL LABORATORY BEFORE BATCH RELEASE. THE DIFFERENCE OF RESULTS INSIDE VIDAS® GROUP COULD BE EXPLAINED BY A MATRIX EFFECT DUE TO THIS SPECIFIC SPECIMEN. IN THE PACKAGE INSERT, IT IS MENTIONED : "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY." INFORMATION FROM (B)(6) RELATED TO THE DIFFERENT BATCHES USED BY THE CUSTOMERS DURING THIS CAMPAIGN OR REGARDING SPECIMEN (B)(6) AND PRE-TESTING RESULTS WAS NOT RECEIVED DESPITE SEVERAL REMINDERS. WITHOUT THIS DATA, FURTHER INVESTIGATION IS NOT POSSIBLE. NO ANOMALY INVOLVING PERFORMANCES WAS IDENTIFIED ON VIDAS® MSG ASSAY.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE RESULT FOR A NEQAS SURVEY SAMPLE ((B)(6)) IN ASSOCIATION WITH THE VIDAS® 3 MEASLES IGG ASSAY. THE EXPECTED RESULT WAS NEGATIVE. THE VIDAS RAW RESULT WAS 0.79, JUST ABOVE EQUIVOCAL. 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 NEQAS SURVEY SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612543 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA 1004457540

    Patients

    Seq Age Sex Outcome Treatment
    1