BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® CA 15-3 ASSAY

    MDR report key: 7323327 · Received March 8, 2018

    Report

    Report Number
    3002769706-2018-00030
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 16, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    LTK
    PMA / PMN Number
    K080469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: TWO (2) CUSTOMER SAMPLES COLLECTED THE (B)(6) 2018 WERE TESTED (RESPECTIVELY IDENTIFIED (B)(6)) ON THE RETAIN KIT OF VIDAS® CA15.3 LOT 1006022590/180930-0 (THE CUSTOMER KITS WERE NOT AVAILABLE ANYMORE). THE TWO (2) SAMPLES WERE TESTED UNDILUTED AND DILUTED: THE TWO (2) SAMPLES WERE FOUND > 400 U/ML WHEN NOT DILUTED. SAMPLE (B)(6) ((B)(6)): GAVE A RESULT OF 648.1 U/ML WHEN DILUTED 1:5 IN DILUENT R1. SAMPLE (B)(6) ((B)(6)): GAVE A RESULT OF 805 U/ML WHEN DILUTED 1:100 IN DILUENT R1. SAMPLE (B)(6) ((B)(6)): GAVE A RESULT OF 657.4 U/ML WHEN DILUTED 1:5 IN DILUENT R1. THE CUSTOMER RESULTS WERE NOT REPRODUCED INTERNALLY. TESTING WAS PERFORMED USING A DILUTION FACTOR 1:100 WHICH GAVE A RESULT HIGHER THAN WITH THE DILUTION RATIO OF 1:5 BUT THIS IS PROBABLY DUE TO THE DILUTION FACTOR ITSELF. THE PACKAGE INSERT STATES UNDER SECTION RESULTS AND INTERPRETATION "SAMPLES WITH CA 15-3 TITERS > 400 U/ML SHOULD BE REASSAYED AFTER MAXIMUM DILUTION BY 1/10 IN CA 15-3" DILUENT". A TEST FOR INTERFERENCE AGAINST HETEROPHILIC ANTIBODIES USING SCANTIBODIES HBT REAGENT: THE RESULTS DID NOT OBSERVE SUCH INTERFERENCE ON THE SAMPLE (B)(6) (23RD OF FEBRUARY) TESTED. ADDITIONAL TESTING USING SPR®S WITH INCORRECT STORAGE CONDITIONS (SOME SPRS WERE STORED IN A POUCH INCORRECTLY CLOSED. NOTE: SPRS ARE VERY SENSITIVE TO HUMIDITY AND CLIP SEAL IS ADDED IN THE VIDAS CA 15.3 KITS. AS EXPLAINED IN THE INSTRUCTION FOR USE, "ONLY REMOVE THE REQUIRED NUMBER OF SPRS FROM THE POUCH AND CAREFULLY RESEAL THE POUCH AFTER OPENING USING THE CLIP SEAL PROVIDED WITH THE KIT." THESE TESTS WERE PERFORMED AT T+7D, T+14D, T+21D BUT WE DID NOT REPRODUCE THE CUSTOMER ISSUE. EVEN IF A DECREASE OF THE SIGNAL AND CONCENTRATION WAS OBSERVED WITH THE SPRS INCORRECTLY STORED THE DECREASE WAS NOT SUFFICIENT TO REACH A CONCENTRATION BELOW 400 U/ML. REGARDING THE CALIBRATION, RESULTS OBTAINED WERE SIMILAR TO THOSE OBTAINED BY THE CUSTOMER ON THE 10TH OF FEBRUARY. MOREOVER, ALL THE CALIBRATION RESULTS WERE SIMILAR TO THE RESULTS OBTAINED BEFORE THE BATCH RELEASE. WITHOUT ANY OF THE CUSTOMER'S CONCERNED KIT(S), IT IS NOT POSSIBLE TO FURTHER INVESTIGATE. THE ANOMALY WAS NOT REPRODUCED INTERNALLY, THE VIDAS® 3 INSTRUMENT USED DID NOT DISPLAY ANY ALARMS. UNFORTUNATELY, WITHOUT THE CUSTOMER CONCERNED KIT(S), IT IS IMPOSSIBLE TO IDENTIFY THE ROOT CAUSE OF THIS ISSUE. HOWEVER, BECAUSE OBTAINED RESULTS WERE OVER 400U/ML, AND BECAUSE THESE RESULTS ARE CONSISTENT TO THOSE OBTAINED BY THE CUSTOMER USING ROCHE CENTRUM TEST (RESPECTIVELY AT 776.3K U/L AND 759 KU/L), IT SEEMS THAT THE INCORRECT RESULTS ARE THE LOWER ONES. ACCORDING TO ALL THE INFORMATION MENTIONED ABOVE, VIDAS® CA15.3 LOT 1006022590/180930-0 IS STILL COMPLIANT WITH THE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A FALSELY OVERESTIMATED (609.55 IU/ML) RESULT IN ASSOCIATION WITH THE VIDAS® CA 15-3 ASSAY. THE CUSTOMER STATED THE PATIENT WAS PRESCRIBED INAPPROPRIATE TREATMENT (FASLODEX®/PALBOCICLIB) BASED ON THE DISCREPANT VIDAS RESULT. A SECOND PATIENT SAMPLE WAS TESTED 10 DAYS LATER, AND THE RESULT WAS MUCH LOWER AT 314.28 IU/ML. BECAUSE OF THIS, THE INITIAL SAMPLE WAS RETESTED AND PROVIDED A RESULT OF 277.19 IU/ML (INSTEAD OF THE INITIAL RESULT OF 609.55 IU/ML). REVIEW OF THIS PATIENT'S VIDAS® CA 15-3 TEST HISTORY INDICATED: (B)(6) 2017, 163.89. (B)(6) 2017, 146.99. (B)(6) 2017, 207.26. (B)(6) 2017, 249.12. (B)(6) 2017, 295.29. (B)(6) 2018, 340.01. (B)(6) 2018, 383.41. (B)(6) 2018, 609.55. (B)(6) 2018, 314.28. ONLY THE RESULT ON (B)(6) 2018 WAS ELEVATED. THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT "SAMPLES WITH CA 15-3 TITERS >400 U/ML SHOULD BE RE-ASSAYED AFTER MAXIMUM DILUTION BY 1/10 IN CA 15-3 DILUENT." THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE IMPACT RELATED TO THE PATIENT'S STATE OF HEALTH. ALTHOUGH VIDAS CA 15-3 ASSAY (REF. 30429) IS NOT SOLD OR MARKETED IN THE UNITED STATES, A SIMILAR PRODUCT (REF. 30429-01) IS SOLD IN THE UNITED STATES. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168514 VIDAS® CA 15-3 ASSAY VIDAS® CA 15-3 ASSAY LTK BIOMERIEUX, SA 30429-01 1006022590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other