BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 5996109 · Received October 4, 2016

    Report

    Report Number
    3002769706-2016-00352
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    August 19, 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 DISCREPANT RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG ASSAY AS COMPARED TO THE LIASON (DIASORIN) METHOD. AN INTERNAL BIOMEREIUX INVESTIGATION WAS PERFORMED. RESULTS ARE AS FOLLOWS: THE CUSTOMER'S SAMPLE WAS NOT SUBMITTED. SINCE OCTOBER 2015, THERE ARE NO OTHER COMPLAINTS FOR VIDAS® MSG BATCH 1004681180 / 161221-0 AND NO RECURRENCE ON OTHER BATCHES OF VIDAS® MSG FOR FALSE NEGATIVE RESULT, FALSE POSITIVE RESULT OR BAD CORRELATION. 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 SEVEN (7) SAMPLES WERE OUT OF RANGE BUT THESE SAMPLES WERE FOUND WITHIN THEIR SEROLOGICAL INTERPRETATION. DURING THE QUALITY CONTROL, A SPECIFICITY AND SENSIBILITY CONTROL WERE PERFORMED: SPECIFICITY CONTROL WAS PERFORMED ON 28 NEGATIVE SERA : ALL SERA WERE FOUND WITHIN THEIR SPECIFICATIONS. SENSIBILITY CONTROL WAS PERFORMED ON 54 POSITIVE SERA : ONE OF THEM WAS FOUND NEGATIVE , IT WAS RETESTED AND FOUND POSITIVE. THE ANALYSIS OF THE CONTROL CARD SHOWED, THAT VIDAS® MSG BATCH 161221-0, WAS IN THE TREND WITH THE OTHER BATCHES AND THE RESULTS WERE IN THEIR SEROLOGICAL INTERPRETATION. THE QUALITY PRODUCT LABORATORY TESTED THREE (3) NEGATIVE AND FOUR (4) POSITIVE INTERNAL MSG BLOOD BANK SAMPLES ON THE RETAIN KIT VIDAS® MSG BATCH 1004681180 / 161221-0: THE RESULTS OBTAINED FOR THESE SEVEN (7) SAMPLES WERE IN THEIR SEROLOGICAL INTERPRETATION. HOWEVER, IN THE ABSENCE OF CUSTOMER'S SAMPLE, IT IS IMPOSSIBLE TO PURSUE FURTHER INVESTIGATIONS. THE PATIENT SEROLOGICAL STATUS HAS NOT CHANGED BETWEEN VIDAS® AND DIASORIN TECHNIQUE. THE PERFORMANCE OF VIDAS® MSG BATCH 1004681180 / 161221-0 ARE WITHIN THE EXPECTED SPECIFICATIONS INDICATED BY THE PACKAGE INSERT

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT THE OCCURRENCE OF DISCREPANT RESULTS IN ASSOCIATION WITH THE VIDAS MEASLES IGG ASSAY AS COMPARED TO THE LIASON (DIASORIN) METHOD. THE VIDAS MEASLES IGG ASSAY PROVIDED A RESULT OF EQUIVOCAL WHEN THE DIASORIN METHOD GAVE A (B)(6) RESULT. 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. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647547 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1