BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 7794435 · Received August 17, 2018

    Report

    Report Number
    3002769706-2018-00150
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    August 17, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    UDI-DI
    03573026064532
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY RECORDS WERE REVIEWED, WITH NO ANOMALY NOTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS: THE COMPLAINT LABORATORY OBSERVED FIVE INTERNAL SAMPLES (TARGET TV: 0.75-0.79-0.99-0.91-0.16) ON FIVE DIFFERENT BATCHES. THE ANALYSIS OF THE CONTROL CHARTS ON THE FIVE INTERNAL SAMPLES SHOWED THAT ALL VIDAS MSG LOT 1005989450 / 180726-0 IS IN THE TREND OF THE PARAMETER. TEST PERFORMED BY COMPLAINT LABORATORY: THE COMPLAINT LABORATORY TESTED FIVE INTERNAL SAMPLES (SAME SAMPLES AS CONTROL CHARTS, SEE ABOVE) WITH THE RETAIN KITS VIDAS MSG LOT 1005989450 / 180726-0. THE RESULTS OF CALIBRATION WERE IN CONFORMANCE TO THE MLE DATA AND ALL SAMPLES WERE WITHIN SPECIFICATIONS. CONCLUSION: ACCORDING THE DATA ABOVE, THE VIDAS MSG KIT, LOT 1005989450 / 180726-0VM IS WITHIN THE EXPECTED PERFORMANCES. ADDITIONALLY, QUALITY CONTROLS ARE NOT IDENTICAL TO PATIENT SAMPLES, AS THE QC MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX AND CONTROL RESULTS. ACCORDING TO COMPLAINTS TREND ANALYSIS, THERE IS NO CURRENT REASON TO SUSPECT A PRODUCT ISSUE ON VIDAS MSG. THE PROBLEM SEEMS TO BE LINKED TO THIS PARTICULAR QUALITY CONTROL WITH VIDAS MSG REAGENT. WITHOUT CUSTOMER'S RETURN SAMPLE, NO FURTHER INVESTIGATION CAN BE PERFORMED NOR PROPOSAL OF A ROOT CAUSE TO THE CUSTOMER ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS WHEN TESTING WITH VIDAS® MEASLES IGG (MSG), REF 30219, FOR A LAB QUALITY CAMPAIGN. FOR THE SAMPLE (B)(6), THE CUSTOMER OBTAINED ON THE VIDAS 3 INSTRUMENT : FIRST RESULT, TEST VALUE =0.48, NEGATIVE. SECOND RESULT (REPETITION OF THE TEST), TEST VALUE= 0.42 NEGATIVE. THE RESULT EXPECTED FOR THIS SAMPLE WAS POSITIVE. THE EXPECTED INTERPRETATION FOR S002 WAS OLD IMMUNITY OR VACCINATED ON LAB QUALITY'S REPORT. CONCERNING THIS LAB QUALITY CAMPAIGN, THERE WERE 50 PARTICIPANTS. THE RESULTS WERE : EIGHT (8) OF THEM REPORTED A NEGATIVE RESULT. FOUR (4) OF THEM REPORTED BORDERLINE RESULT. AND 38 REPORTED POSITIVE RESULT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636449 VIDAS® MEASLES IGG VIDAS® MSG LJB BIOMERIEUX SA 1005989450 03573026064532

    Patients

    Seq Age Sex Outcome Treatment
    1