BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® CA 15-3 ASSAY

    MDR report key: 7664538 · Received July 5, 2018

    Report

    Report Number
    3002769706-2018-00095
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    LTK
    PMA / PMN Number
    K080469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO THE REPORT OF HIGH VALUES FOR THE POSITIVE CONTROL C1 (OUT OF RANGE) USING VIDAS® CA 15.3 (REFERENCE 30429). QUALITY CONTROL RECORDS: NO NON-CONFORMITY OR CAPA LINKED TO THE CUSTOMER'S COMPLAINT WERE RECORDED ON VIDAS CA 15.3 PARAMETER REFERENCE 30429. ANALYSIS OF THE BATCH HISTORY RECORDS: THERE WAS NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: AT LEAST FIVE (5) INTERNAL SAMPLES ON FIVE (5) VIDAS CA 15.3 LOTS INCLUDING LOTS 1006022590 / 180930-0 AND 1006251930 / 181204-0. ALL RESULTS WERE WITHIN THE EXPECTED SPECIFICATIONS AND TWO (2) LOTS WERE WITHIN THE TREND OF PARAMETER. TESTS PERFORMED BY BIOMÉRIEUX COMPLAINT LABORATORY: 1) ON CUSTOMER'S KIT LOT 1006251930 / 181204-0. C1 OUT OF RANGE HIGH REPRODUCED (S1 VERY LOW BUT WITHIN MLE SPECIFICATIONS). 2) ON RETAINED KIT LOT 1006251930 / 181204-0. ONE (1) C1 ON THREE (3) OUT OF RANGE HIGH AND S1 SIGNAL DECREASE ABOUT 30% SINCE BATCH RELEASE. 3) ON RETAINED KIT LOT 1006022590 / 180930-0. C1 OUT OF RANGE NOT REPRODUCED BUT S1 SIGNAL DECREASE ABOUT 20% SINCE BATCH RELEASE. BIOMÉRIEUX INDUSTRIALIZATION DEPARTMENT : CUSTOMER'S ISSUE CONFIRMED AND LINKED TO A SPECIFIC RAW MATERIAL LOT ENTERING IN THE COMPOSITION OF S1 LOT 1420320 COMMON TO VIDAS CA 15.3 LOTS 1006022590 / 180930-0 AND 1006251930 / 181204-0. IMPACT ON PATIENT'S RESULT: NO RISK OF FALSE PATIENT RESULTS BECAUSE THE PROBLEM AFFECTS ONLY THE BATCH OF S1, THE IMPACT IS ONLY A DELAY ON RESULTS CONCLUSION: ACCORDING TO ALL INFORMATION ABOVE, HIGH VALUES FOR THE POSITIVE CONTROL C1 (OUT OF RANGE) USING VIDAS CA 15.3 REFERENCE 30429 LOTS 1006022590 / 180930-0 AND 1006251930 / 181204-0 WERE REPRODUCED. ROOT CAUSE OF THE ISSUE IS IDENTIFIED AS A RAW MATERIAL USED IN S1 MANUFACTURING. AS A CONSEQUENCE, FOLLOWING ACTIONS WERE IMPLEMENTED : RAW MATERIAL IDENTIFIED AS ROOT CAUSE OF THE ISSUE WAS BLOCKED AND DID NOT ENTER ANY OTHER PRODUCT MANUFACTURING. PRODUCT SHIPMENT WAS STOPPED THROUGH PSS 3974 SEND ON 05JUL2018. FCA 3976 WAS ISSUED ON 13JUL2018 TO ASK DISTRIBUTORS AND CUSTOMERS TO DESTROY THEIR REMAINING STOCK OF THE VIDAS CA 15.3 LOTS 1006022590 / 180930-0 AND 1006251930 / 181204-0. CORRECTIVE ACTIONS WILL BE IMPLEMENTED THROUGH CORRECTIVE ACTIONS PREVENTIVE ACTIONS (CAPA). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED DISCREPANT RESULTS FOR A PATIENT'S SAMPLES IN ASSOCIATION WITH THE VIDAS® CA 15-3 ASSAY. ON (B)(6) 2018 RESULTS: VIDAS® TEST RESULT: 33.68 IU/ML. ROCHE TEST: 88.90 IU/ML. ON (B)(6) 2018 RESULTS: VIDAS® TEST: 43.28 IU/ML. ON (B)(6) 2018 RESULTS: VIDAS® TEST: 41.98 IU/ML. ROCHE TEST: 64.20 IU/ML. THE CUSTOMER STATED THE INCORRECT RESULT WAS REPORTED TO THE CLINICIAN, AND THAT THE RESULT AFFECTED PATIENT TREATMENT. THE CUSTOMER STATED THAT THERE WAS A MISDIAGNOSIS AND THEY THOUGHT THE PATIENT WAS DOING BETTER WHEN IN FACT THE PATIENT WAS NOT DOING BETTER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506626 VIDAS® CA 15-3 ASSAY VIDAS® CA 15-3 ASSAY LTK BIOMERIEUX, S.A. 1006022590

    Patients

    Seq Age Sex Outcome Treatment
    1