BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MUMPS IGG ASSAY

    MDR report key: 7286082 · Received February 21, 2018

    Report

    Report Number
    3002769706-2018-00018
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    October 31, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    LJY
    UDI-DI
    03573026064525
    PMA / PMN Number
    K923903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES REGARDING A FALSE POSITIVE RESULT FOR A CAP SURVEY (SAMPLE VR3M-02) IN ASSOCIATION WITH VIDAS® MUMPS IGG 60TESTS. ON 31OCT2017, THE CUSTOMER TESTED THE SURVEY SAMPLE WITH VIDAS MUMPS IGG AND OBTAINED A POSITIVE RESULT WHEN THE EXPECTED RESULT WAS NEGATIVE. THE SAMPLE WAS RETESTED ON 22JAN2018 AND WAS ALSO POSITIVE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. RESULTS OBTAINED BY VIDAS MPG PEER GROUP FOR THE CAPSURVEY VR3M-02 : - 19 NEGATIVE RESULTS, - 136 EQUIVOCAL RESULTS, - 17 POSITIVE RESULTS. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR THE LOT SHOWS NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. BIOMÉRIEUX TESTED SIX (6) INTERNAL SAMPLES (4 POSITIVE SAMPLES AND 2 NEGATIVE SAMPLES) ON THE RETAIN KIT VIDAS MUMPS IGG LOT 1005750680 / 180413-0. ALL OF THE RESULTS OBTAINED ARE IN THEIR SPECIFICATION. BIOMÉRIEUX STUDIED THE CONTROL CHARTS ON FIVE (5) VIDAS MUMPS IGG BATCHES (INCLUDING THIS BATCH) ON SIX (6) INTERNAL SAMPLES WITH FOLLOWING TARGETS: - 1 POSITIVE SAMPLE MPG1 WITH TARGET AT 0.58 TV, - 1 POSITIVE SAMPLE MPG4 WITH TARGET AT 0.70 TV, - 1 POSITIVE SAMPLE MPG9 WITH TARGET AT 0.73 TV, - 1 POSITIVE SAMPLE MPG17 WITH TARGET AT 0.96 TV, - 1 NEGATIVE SAMPLE MPG7 WITH TARGET AT 0.06 TV, - 1 NEGATIVE SAMPLE MPG21 WITH TARGET AT 0.25 TV. THE RESULTS WERE CONSISTENT WITH THEIR SEROLOGICAL INTERPRETATION. VIDAS MUMPS IGG BATCH 1005750680 / 180413-0 IS IN THE TREND OF THE OTHER BATCHES. IN CONCLUSION, THE SPECIFICITY FOR VIDAS MUMPS IGG 1005750680 / 180413-0 IS IN THE EXPECTED PERFORMANCES. ACCORDING TO THE DATA MENTIONED ABOVE AND THE DIFFERENT RESULTS OBTAINED WHATEVER THE METHOD USED, IT SEEMS THAT THE ISSUE IS NOT LINKED TO THE VIDAS MUMPS IGG REAGENT NOR TO THE BATCH. THE ROOT CAUSE OF THIS ISSUE IS PROBABLY LINKED TO THE EQA AND ITS MANUFACTURING PROCESS. THE HYPOTHESIS IS PROBABLY DUE TO A QC MATERIAL WITH A CONCENTRATION CLOSE TO THE CUT OFF. QC SAMPLES ARE NOT IDENTICAL TO PATIENT SAMPLES, QC MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX AND CONTROL RESULTS. ACCORDING TO ALL THE DATA MENTIONED ABOVE, VIDAS MUMPS IGG 1005750680 / 180413-0 IS STILL COMPLIANT TO ITS PERFORMANCE SPECIFICATION. THIS CHALLENGE WAS NOT GRADED BY CAPSURVEY DUE TO THE ABSENCE OF THE PARTICIPANT CONSENSUS (RESULT FROM NEGATIVE TO POSITIVE INTERPRETATION WITH THE DIFFERENT METHODS).

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED A FALSE POSITIVE RESULT FOR A CAP SURVEY SAMPLE IN ASSOCIATION WITH VIDAS® MUMPS IGG 60TESTS. ON (B)(6) 2017, THE CUSTOMER TESTED THE SURVEY SAMPLE WITH VIDAS MUMPS IGG AND OBTAINED A POSITIVE RESULT WHEN THE EXPECTED RESULT WAS NEGATIVE. THE SAMPLE WAS RETESTED ON (B)(6) 2018 AND WAS ALSO POSITIVE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130777 VIDAS® MUMPS IGG ASSAY VIDAS® MUMPS IGG ASSAY LJY BIOMERIEUX, SA 1005750680 03573026064525

    Patients

    Seq Age Sex Outcome Treatment
    1