BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 9765946 · Received February 27, 2020

    Report

    Report Number
    8020790-2020-00020
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    UDI-DI
    03573026064532
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN IRELAND REGARDING FALSE NEGATIVE RESULTS FOR TWO NEQAS SURVEY STRAINS IN ASSOCIATION WITH VIDAS® MEASLES IGG (REF. 30219 LOT 1007322860). A BIOMÉRIEUX INTERNAL INVESTIGATION WAS COMPLETED. THERE IS NO OTHER COMPLAINT FOR AN EXTERNAL QUALITY CONTROL PROBLEM ON THE VIDAS MSG BATCH 1007322860 / 200325-0. NO RECURRENCE OF A PARTICULAR ANOMALY. ACCORDING TO THE ANALYSIS OF THE QUALITY DATA, THERE WAS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING STAGES. NO CAPA OR NON-COMPLIANCE IS RELATED TO THE REASON FOR THE COMPLAINT. CONTROL CARDS WERE USED WITH FIVE POSITIVE SERA FROM INTERNAL SEROTHEQUE THAT WERE ANALYZED ON EIGHT LOTS OF VIDAS MSG INCLUDING THE CLIENT LOT. ALL THE SAMPLES ANALYZED COMPLIED WITH THE SPECIFICATION, BUT VIDAS MEASLES IGG LOT 1007322860 / 200325-0 WAS IN THE LOW TREND COMPARED TO THE OTHER LOTS. THE COMPLAINT LABORATORY TESTED THE VIDAS MSG PV KIT 1007322860 / 200325-0, A BIOBANK SERUM 156234-SER, AS WELL AS FIVE SERUMS FROM INTERNAL SEROTHEQUE. INTERNAL SERUMS WERE WITHIN EXPECTED STANDARDS ALTHOUGH SOME WERE LOCATED ON THE LOWER LIMIT. SERUM 156234-SER FROM BIOBANK OBTAINED A NEGATIVE RESULT ON LOT 200325-0 BUT WAS POSITIVE ON DIASORIN. VMS (VALIDATION, METROLOGY, SUPPORT) INVESTIGATED SAMPLE 5248 AND SAMPLE 5249. SAMPLE 5248 WAS NEGATIVE FOR ALL THREE LOTS. SAMPLE 5249 WAS NEGATIVE FOR TWO LOTS AND POSITIVE FOR ONE. IT WAS CONCLUDED THAT THE INTER-BATCH VARIABILITY WAS CONSISTENT WITH THE PRECISION PROFILE OF THE PARAMETER. NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE LOTS OF VIDAS MSG. IN CONCLUSION, THE VIDAS MSG 1007322860 / 200325-0 BATCH STILL COMPLIED WITH ITS SPECIFICATIONS..

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR TWO NEQAS SURVEY STRAINS IN ASSOCIATION WITH VIDAS® MEASLES IGG (REF. 30219 LOT 1007322860). BOTH SURVEY STRAINS WERE TESTED IN DUPLICATE, RESULTS WERE: NEQAS STRAIN 5248: 0.4, 0.42 NEGATIVE; NEQAS STRAIN 5249: 0.49, 0.40 NEGATIVE. IT WAS CONFIRMED THE EXPECTED RESULT FOR BOTH NEQAS SURVEY STRAINS WAS POSITIVE. AS THERE ARE NO PATIENTS ASSOCIATED WITH THESE QUALITY CONTROL STRAINS, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226680 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX SA 30219 1007322860 03573026064532

    Patients

    Seq Age Sex Outcome Treatment
    1