BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 5963708 · Received September 20, 2016

    Report

    Report Number
    3002769706-2016-00343
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Report Date
    August 23, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF FALSE NEGATIVE AND FALSE EQUIVOCAL RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG ASSAY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. RESULTS ARE AS FOLLOWS: THE CUSTOMER'S SAMPLE WAS NOT SUBMITTED. SINCE OCTOBER 2015, THERE IS NO OTHER COMPLAINT RELATED SENSITIVITY PROBLEM FOR VIDAS® MSG BATCH 1004802610 / 170302-0. THERE IS NO CAPA, NOR NON CONFORMITY FOR A SIMILAR ISSUE IN RELATION TO THE CUSTOMER'S COMPLAINT. THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED THAT FOUR (4) SAMPLES WERE OUT OF RANGE BUT THESE SAMPLES WERE FOUND WITHIN THEIR INTERPRETATION. DURING THE QUALITY CONTROL PROCESS, A SPECIFICITY CONTROL WAS PERFORMED ON 28 NEGATIVE SERA AND 54 POSITIVE SERA. ALL SERA WERE FOUND WITHIN THEIR SPECIFICATIONS. THE ANALYSIS OF THE CONTROL CARD OF EACH SAMPLE TESTED SHOWED THAT VIDAS® MSG BATCH 170302-0 WAS IN THE TREND WITH THE OTHER BATCHES. THE QUALITY PRODUCT LABORATORY TESTED TWO (2) INTERNAL NEGATIVE AND TWO (2) INTERNAL POSITIVE SAMPLES ON THE RETAIN KIT VIDAS® MSG BATCH 1004802610 / 170302-0. THE RESULTS OBTAINED FOR THE FOUR (4) SAMPLES WERE WITHIN THEIR SPECIFICATIONS. THE PERFORMANCE OF VIDAS® MSG BATCH 170302-0 ARE WITHIN THE EXPECTED SPECIFICATIONS INDICATED IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) CONTACTED BIOMERIEUX TO REPORT THE OCCURRENCE OF FALSE NEGATIVE AND FALSE EQUIVOCAL RESULTS IN ASSOCIATION WITH THE VIDAS MEASLES IGG ASSAY. TESTING OF SPECIMENS BY REFERENCE LABORATORY OBTAINED A RESULT OF POSITIVE. THE CUSTOMER STATED THAT TWO (2) RESULTS FROM THE REFERENCED LOT WERE CONFIRMED AS FALSE NEGATIVE. INITIAL RESULTS WERE 0.37 AND 0.49 INDICATING A NEGATIVE WHICH WERE LATER CONFIRMED AS A POSITIVE. THE CUSTOMER INDICATED DELAYS OF BETWEEN 10-14 DAYS WHEN A FALSE NEGATIVE IS REPORTED, WHICH WILL DELAY TREATMENT AS THE CUSTOMER IS SENDING ALL NEGATIVES TO A DIFFERENT HOSPITAL. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615271 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA 1004802610

    Patients

    Seq Age Sex Outcome Treatment
    1