BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE RPR CARD TEST

    MDR report key: 11941103 · Received June 4, 2021

    Report

    Report Number
    3008352382-2021-00157
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    00382902750055
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    H6: INVESTIGATION SUMMARY: SEROLOGY TEST WAS PERFORMED AND SATISFACTORY RESULTS WERE OBTAINED. VISUAL INSPECTION AND BATCH RECORD REVIEW WAS PERFORMED NO DISCREPANCIES WERE FOUND. NO PHOTO OR RETURNED GOODS WERE AVAILABLE WE WERE UNABLE TO REPRODUCE CUSTOMER EXPERIENCE. COMPLAINT UNCONFIRMED BASED ON RETENTION AND BATCH RECORD REVIEW. ALTHOUGH WE ARE UNABLE TO REPRODUCE CUSTOMER CLAIM, 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST A PHYSICAL DEFECT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PARTICLES ARE TOO THICK".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST A PHYSICAL DEFECT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PARTICLES ARE TOO THICK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836287 BD MACRO-VUE RPR CARD TEST ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 275005 0092426 00382902750055

    Patients

    Seq Age Sex Outcome Treatment
    1