BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD TEST

    MDR report key: 15788970 · Received November 14, 2022

    Report

    Report Number
    1119779-2022-01386
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GMQ
    UDI-DI
    00382902750055
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 275005, BATCH 2013911 SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FO.R 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. NORMAL PARTICLE SIZE WAS OBSERVED. 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. PHOTO WAS EVALUATED AND NORMAL SIZE OF THE PARTICLE WERE SHOWED. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FAX #: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MACRO-VUE¿ RPR CARD TEST THAT THERE IS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE PARTICULAR LOT NUMBER OF BD MACRO-VUE SYPHILIS RPR REAGENT WHICH SEEMS TO BE PERFORMING DIFFERENTLY COMPARED TO EXPECTED PERFORMANCE. LOT NUMBER 2013911 WITH EXPIRY 31/01/2024 SEEMS TO BE MORE GRANULAR IN CONSISTENCY HOWEVER WHEN TESTED WITH A PATIENT SAMPLE IT IS LEADING TO UNDER-REPORTING OF RPR TITRES. WE HAVE COMPARED IT TO A NEWER LOT 2094445 WITH EXPIRY 30/04/24 AND THIS IS PERFORMING AS EXPECTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MACRO-VUE¿ RPR CARD TEST THAT THERE IS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE PARTICULAR LOT NUMBER OF BD MACRO-VUE SYPHILIS RPR REAGENT WHICH SEEMS TO BE PERFORMING DIFFERENTLY COMPARED TO EXPECTED PERFORMANCE. LOT NUMBER 2013911 WITH EXPIRY 31/01/24 SEEMS TO BE MORE GRANULAR IN CONSISTENCY HOWEVER WHEN TESTED WITH A PATIENT SAMPLE IT IS LEADING TO UNDER-REPORTING OF RPR TITRES. WE HAVE COMPARED IT TO A NEWER LOT 2094445 WITH EXPIRY 30/04/24 AND THIS IS PERFORMING AS EXPECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416531 BD MACRO-VUE¿ RPR CARD TEST ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON, DICKINSON & CO. (SPARKS) 275005 2013911 00382902750055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown