BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 5434235 · Received February 12, 2016

    Report

    Report Number
    3002769706-2016-00033
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    October 16, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES REPORTED DISCREPANT RESULTS ASSOCIATED WITH VIDAS® MEASLES IGG TEST LOT 1003910510 AND ANOTHER METHOD (QUEST). RESULTS OF THE INTERNAL BIOMÉRIEUX INVESTIGATION ARE AS FOLLOWS: THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY, BUT SOME POSITIVE SERA WERE FOUND OUTSIDE OF THE INTERNAL NORMS; HOWEVER, WITHOUT CHANGING OF SEROLOGICAL INTERPRETATIONS. NO OTHER COMPLAINT WAS RECORDED FOR VIDAS® MEASLES IGG LOT 1003910510/160213-0 . NO POSSIBILITY TO TEST SAMPLES DUE TO THE EXPIRATION OF VIDAS® MEASLES IGG LOT 1003910510/160213-0 AS OF 13FEB2016. VIDAS® MEASLES IGG PERFORMANCE DOES NOT CLAIM 100% IN TERMS OF SPECIFICITY OR SENSITIVITY. WITHOUT THE QUEST PERFORMANCE DATA (SENSITIVITY AND SPECIFICITY) AND THE LACK OF A THIRD METHOD, IT IS NOT POSSIBLE TO DETERMINE WHICH RESULT IS CORRECT BETWEEN THE TWO (2) METHODS. IN CONCLUSION, NO PRODUCT PROBLEM WAS IDENTIFIED FOR VIDAS® MEASLES IGG LOT 1003910510/160213-0.

    Description of Event or Problem · 1

    A CUSTOMER AT "(B)(6)" REPORTED DISCREPANT RESULTS IN THREE PATIENTS WITH MEASLES WHILE USING; VIDAS® MEASLES IGG TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91556 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA 1003910510

    Patients

    Seq Age Sex Outcome Treatment
    1