BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    MDR report key: 12375250 · Received August 26, 2021

    Report

    Report Number
    2647876-2021-00054
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    30382902703090
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR SHOULD BE CONSIDERED CANCELLED. IN THIS PARTICULAR EVENT, THE DIAGNOSTIC TEST IS PERFORMED WITH THE UNDERSTANDING AND RECOMMENDATION TO PERFORM CONCURRENT CONTROLS TO ASSURE ACCURACY. THEREFORE, ERRONEOUS RESULTS WOULD BE SUSPECTED AND LEAD TO RETESTING. THIS WILL NOT LIKELY LEAD TO A SERIOUS ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION ATYPICAL GROWTH 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: " IT WAS REPORTED THAT THERE WAS LOWER REACTIVITY WITH THE NEW RPR LOT# 1123493. ".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION ATYPICAL GROWTH 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: IT WAS REPORTED THAT THERE WAS LOWER REACTIVITY WITH THE NEW RPR LOT# 1123493.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273111 BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 270309 1123493 30382902703090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown