BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG II

    MDR report key: 7803044 · Received August 21, 2018

    Report

    Report Number
    3002769706-2018-00154
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K080766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN SWITZERLAND REPORTED A FALSE POSITIVE RESULT FOR EQA (EXTERNAL QUALITY ASSESSMENT ) SAMPLES WHEN TESTING WITH VIDAS® RUB IGG II (REF. 30221) LOT 1006264820. THE CONCERNED EQA SAMPLE IS 2018-2R1 FROM SRK ORGANIZATION (SWISS EQA PROVIDER). AN INTERNAL INVESTIGATION WAS PERFORMED. THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. A COMPLAINT TRENDING ANALYSIS CONFIRMED THERE IS NO OTHER COMPLAINT RECORDED ON VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 CONCERNING EQA. STUDY OF INTERNAL SAMPLES CONTROL CHARTS INCLUDED: FIVE INTERNAL SAMPLES WITH DIFFERENT CONCENTRATIONS (TARGET : 13.3UI/ML, 11.5 UI/ML, 9.87 UI/ML AND 4.07 UI/ML), FIVE BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER. VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 IS IN THE TREND ANALYSIS COMPARED TO THE OTHER BATCHES. TEST PERFORMED: FIVE INTERNAL SAMPLES (TARGET : 13.3UI/ML, 11.5 UI/ML, 9.87 UI/ML AND 4.07 UI/ML) WERE TESTED ON THE VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0. ALL THE SAMPLES WERE WITHIN THEIR ACCEPTABLE RANGE. THERE WAS NO OBSERVATION OF ANY EVOLUTION, COMPARED TO THE RESULTS OBTAINED BEFORE THE RELEASE OF VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0. THE CUSTOMER SAMPLE, EQA SRK 2018-2R1, WAS TESTED USING VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 AND THE RESULT WAS FOUND POSITIVE (42UI/ML). THE CUSTOMER RESULT WAS REPRODUCED. IT WAS NOT POSSIBLE TO PURSUE FURTHER TESTS AS THERE WAS NO REMAINING VOLUME. OTHER EQA ANALYSIS: AS BIOMÉRIEUX SUBSCRIBES TO EXTERNAL QUALITY ASSESSMENT PROGRAMS, AN ANALYSIS OF THE RESULTS OBTAINED ON CTCB PROGRAM (FRENCH EQA PROVIDER PROGRAM) IN 2018 FOR VIDAS RUB IGG II WAS PERFORMED. THIS ANALYSIS SHOWED THAT RESULTS FOR TWO POSITIVE CONTROLS WERE COMPLIANT TO THE PEER GROUP RESULTS AND REACHED THE EXPECTATIONS. CONCLUSION: TESTING REPRODUCED THE POSITIVE RESULT WHEN TESTING SRK 2018-R1 WITH VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0. NEVERTHELESS, ACCORDING TO SRK REPORT, THIS POSITIVE RESULT OBTAINED FOR EQA SRK 2018-2R1USING VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 IS CONSIDERED AS CONFORMING. THERE IS NO INFORMATION IN HAND REGARDING THE CONTROL COMPOSITION, OR THE METHOD USED TO DETERMINE THE EQUIVOCAL STATUS OF THIS QUALITY CONTROL MATERIAL. MOREOVER, QUALITY CONTROL SAMPLES ARE NOT IDENTICAL TO PATIENT SAMPLES, QUALITY CONTROL MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX AND CONTROL RESULTS. ACCORDING TO THE DATA MENTIONED ABOVE, THE BATCH VIDAS RUB IGG II REFERENCE 30221 BATCH 1006264820 / 190125-0 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS WHEN TESTING A QUALITY CONTROL SAMPLE WITH VIDAS® RUB IGG II (REF. 30221), LOT 1006264820. THE CUSTOMER PERFORMED A ROUND ROBIN TEST AS PART OF AN EXTERNAL QC TRIAL FROM SRK. THE RESULT IS EXPECTED TO BE BORDERLINE/EQUIVOCAL. THE TECHNIQUES USED TO TEST THE SAMPLES WERE: ABBOTT RUBELLA, ARCHITECT; BIOMÉRIEUX RUBELLA; DIASORIN; ROCHE RUBELLA; SIEMENS RUBELLA. THE CUSTOMER TESTED THE SAMPLE TWICE, AND BOTH RESULTS WERE POSITIVE AT 42 IU/ML AND 46 IU/ML. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644968 VIDAS® RUB IGG II VIDAS® RUB IGG II LFX BIOMERIEUX SA 1006264820

    Patients

    Seq Age Sex Outcome Treatment
    1