BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD TEST

    MDR report key: 14687696 · Received June 14, 2022

    Report

    Report Number
    2647876-2022-00157
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    April 14, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    00382902750055
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY. CONTROL LOT (2013911) CUSTOMER BATCH NUMBER (1277599) SERUM NO. 15: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO'S; 17 - 20: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 26, 37 AND 40: ALL LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1 SERUM NO'S.1, 7 AND 8: ALL LOTS SHOWED NEGATIVE RESULTS. FROM THE PHOTO RECEIVED WE CANNOT IDENTIFY POSITIVE REACTIVE WELL IN ANY OF THE CARDS REACTION UNABLE TO REPRODUCE CUSTOMER EXPERIENCE. COMPLAINT UNCONFIRMED BASED OF RETENTION SAMPLE RESULTS, PHOTO EVALUATION AND BATCH HISTORY RECORD REVIEW.. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. SPECIAL ATTENTION SHOULD BE PROVIDED TO: ANTIGEN STORAGE AND USE. SAMPLE AND ROOM TEMPERATURE DURING THE TEST. TYPE OF SPECIMEN USED: COLLECTION AND PREPARATION. ACCORDING OF THE ¿MANUAL OF TEST FOR SYPHILIS¿ EDITION 9.0 THE FOLLOWING ¿SOURCES OF ERROR¿ HAD BEEN IDENTIFIED FOR INCREASE OF REACTIVITY OR FALSE REACTIVITY FOR THE RPR TEST. IF THE TIME OF ROTATION IS TOO LONG, TEST REACTIVITY MAY BE INCREASED. IF THE CARD IS EXCESSIVELY ROTATED AND TILTED (TO AND FRO MOTIONS) BY HAND AFTER REMOVAL FROM THE ROTATOR, A FALSE REACTIVE RESULT MAY OCCUR. IF THE SERUM IS UNEVENLY SPREAD IN THE CIRCLE, THE ANTIGEN AND THE ANTIBODY MAY NOT MIX PROPERLY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD MACRO-VUE¿ RPR CARD TEST HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DOUBTFUL RESULTS ARE PRESENTED WITH SOME KITS, SPECIFICALLY WITH THOSE THAT WERE RECEIVED ON 02/10. WE CARRIED OUT A TEST COMPARING REAGENTS RECEIVED ON 03/17 THAT ARE FROM THE SAME LOT (1277599) BUT THE RESULTS ARE CLEARLY DIFFERENT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD MACRO-VUE¿ RPR CARD TEST HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DOUBTFUL RESULTS ARE PRESENTED WITH SOME KITS, SPECIFICALLY WITH THOSE THAT WERE RECEIVED ON 02/10. WE CARRIED OUT A TEST COMPARING REAGENTS RECEIVED ON 03/17 THAT ARE FROM THE SAME LOT (1277599) BUT THE RESULTS ARE CLEARLY DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489746 BD MACRO-VUE¿ RPR CARD TEST ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 275005 1277599 00382902750055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown