BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD TEST

    MDR report key: 15765920 · Received November 9, 2022

    Report

    Report Number
    2647876-2022-00225
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 5, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    00382902750055
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY: CONTROL LOT (2222697) CUSTOMER BATCH NUMBER (2013911) SERUM NO. 12: CONTROL, RETURNED GOODS AND RETENTION, SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO'S; 17 ¿ 20 : CONTROL, RETUNED GOOD AND RETENTION SHOWED REACTIVE RESULTS AT 1:1 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 26, 36 AND 40 : CONTROL, RETURNED GOOD AND RETENTION SAMPLE SHOWED REACTIVE MINIMAL RESULTS AT 1:1 . SERUM NO'S.8, 9 AND 10: ALL LOTS SHOWED NEGATIVE RESULTS. VISUAL INSPECTION WAS PERFORMED TO RETENTION SAMPLES AND RETURNED GOODS RECEIVED, NO DISCREPANCY WERE FOUND. NO AGGLUTINATION, NORMAL PARTICLE SIZE WAS OBSERVED. MATERIAL PERFORMED AS EXPECTED. DHR BATCH HISTORY RECORDS WERE REVIEWED WITH SATISFACTORY RESULTS, NO DEVIATIONS WERE REPORTED. IN-PROCESS AND QC TESTING WERE WITHIN SPECIFICATION BATCH RECORD REVIEW DO NOT SHOW ANY DISCREPANCY. COMPLAINT UNCONFIRMED BASED OF RETENTION SAMPLE, RETURNED GOODS TEST RESULTS, BATCH HISTORY RECORD REVIEW. 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. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. H3 OTHER TEXT : SEE H.10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDER AND RECEIVED10 (X3 VIALS) OF RPR ANTIGEN ON THE 1/9/2022 WITH LOT #2013911 EXP 31/1/24, CAT #275005. WE WERE USING THIS ANTIGEN LOT # WITHOUT ANY ISSUES UP UNTIL YESTERDAY (26/10/22) WHEN WE NOTICED OUR NEGATIVE CONTROL STARTED LOOKING SLIGHTLY POSITIVE (WEAK AGGLUTINATION). THE NEGATIVE PATIENTS ALSO APPEARED TO BE GIVING THIS SAME PATTERN OF WEAK AGGLUTINATION. TODAY (27/10/22) THE NEGATIVE CLEARLY WAS NOT NEGATIVE ALONG WITH MANY OF OUR PATIENT SAMPLES. WE OPENED A NEW VIAL OF ANTIGEN FROM THE SAMPLE PACKAGE OF 3 AND OBTAINED THE SAME RESULTS. WE THEN OPEN A NEW VIAL FROM ANOTHER PACKAGE AND AGAIN GOT THE SAME RESULTS (WEAKLY POSITIVE NEG CONTROL). THIS IS THE STAGE I CONTACTED MICHELLE KERR FROM BD ABOUT THE OBSERVATIONS WE WERE SEEING TO CHECK IF ANY OTHER LABS HAD REPORTED A SIMILAR ISSUE. AFTER FURTHER DISCUSSIONS WITH MICHELLE WE DECIDED TO TEST ALL THE UNOPENED PACKAGES OF RPR ANTIGEN TO DETERMINE IF THE OBSERVATION ABOUT THE NEGATIVE CONTROL AND NEGATIVE PATIENTS SHOWING A WEAK AGGLUTINATION PATTERN WAS CONSISTENT. WHEN ALL THE PACKAGES WERE OPENED WE NOTICED THAT SOME OF THE PACKAGES APPEARED TO HAVE A DIFFERENT SHADE OF GREY TO THE RPR ANTIGEN. SOME VIALS APPEARED QUITE PALE WHILE OTHERS APPEARED MUCH DARKER IN COLOUR. WE THEN TESTED ONE OF THE DARKER VIALS AND GOT ALL NEGATIVE RESULTS AS EXPECTED. THIS DIFFERENCE IN COLOUR COULD EXPLAIN WHY WE ARE SEEING VARIABLE RESULTS WITH THIS BATCH NUMBER OF ANTIGEN. IN TOTAL WE HAVE 15 VIALS OF RPR ANTIGEN UN OPENED, 6 APPEAR TO BE DARKER IN COLOUR AND GIVES US THE RESULTS WE ARE LOOKING FOR AND THE 9 LIGHTER VIALS SEEM TO GIVE US FALSE POSITIVE RESULTS. I HAVE INCLUDED A PICTURE BUT ITS DIFFICULT TO SEE THE DIFFERENT SHADES OF GREY BUT I ASSURE YOU THAT THERE IS CLEARLY A DIFFERENCE WHEN WE LOOKED AT THEM. THE ONE ON THE LEFT IS THE DARKER VIAL.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDER AND RECEIVED 10 (X3 VIALS) OF RPR ANTIGEN ON THE 1/9/2022 WITH LOT #2013911 EXP 31/1/24, CAT #275005. WE WERE USING THIS ANTIGEN LOT # WITHOUT ANY ISSUES UP UNTIL YESTERDAY (B)(6) 2022 WHEN WE NOTICED OUR NEGATIVE CONTROL STARTED LOOKING SLIGHTLY POSITIVE (WEAK AGGLUTINATION). THE NEGATIVE PATIENTS ALSO APPEARED TO BE GIVING THIS SAME PATTERN OF WEAK AGGLUTINATION. TODAY (B)(6) 2022 THE NEGATIVE CLEARLY WAS NOT NEGATIVE ALONG WITH MANY OF OUR PATIENT SAMPLES. WE OPENED A NEW VIAL OF ANTIGEN FROM THE SAMPLE PACKAGE OF 3 AND OBTAINED THE SAME RESULTS. WE THEN OPEN A NEW VIAL FROM ANOTHER PACKAGE AND AGAIN GOT THE SAME RESULTS (WEAKLY POSITIVE NEG CONTROL). THIS IS THE STAGE I CONTACTED (B)(6) FROM BD ABOUT THE OBSERVATIONS WE WERE SEEING TO CHECK IF ANY OTHER LABS HAD REPORTED A SIMILAR ISSUE. AFTER FURTHER DISCUSSIONS WITH (B)(6) WE DECIDED TO TEST ALL THE UNOPENED PACKAGES OF RPR ANTIGEN TO DETERMINE IF THE OBSERVATION ABOUT THE NEGATIVE CONTROL AND NEGATIVE PATIENTS SHOWING A WEAK AGGLUTINATION PATTERN WAS CONSISTENT. WHEN ALL THE PACKAGES WERE OPENED WE NOTICED THAT SOME OF THE PACKAGES APPEARED TO HAVE A DIFFERENT SHADE OF GREY TO THE RPR ANTIGEN. SOME VIALS APPEARED QUITE PALE WHILE OTHERS APPEARED MUCH DARKER IN COLOUR. WE THEN TESTED ONE OF THE DARKER VIALS AND GOT ALL NEGATIVE RESULTS AS EXPECTED. THIS DIFFERENCE IN COLOUR COULD EXPLAIN WHY WE ARE SEEING VARIABLE RESULTS WITH THIS BATCH NUMBER OF ANTIGEN. IN TOTAL WE HAVE 15 VIALS OF RPR ANTIGEN UN OPENED, 6 APPEAR TO BE DARKER IN COLOUR AND GIVES US THE RESULTS WE ARE LOOKING FOR AND THE 9 LIGHTER VIALS SEEM TO GIVE US FALSE POSITIVE RESULTS. I HAVE INCLUDED A PICTURE BUT ITS DIFFICULT TO SEE THE DIFFERENT SHADES OF GREY BUT I ASSURE YOU THAT THERE IS CLEARLY A DIFFERENCE WHEN WE LOOKED AT THEM. THE ONE ON THE LEFT IS THE DARKER VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650927 BD MACRO-VUE¿ RPR CARD TEST ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 275005 2013911 00382902750055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown