BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD TEST

    MDR report key: 16441494 · Received February 27, 2023

    Report

    Report Number
    3008352382-2023-00006
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 24, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    PMA / PMN Number
    NA
    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

    H.6 INVESTIGATION SUMMARY: SEROLOGY TEST RESULTS: SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY USING CARDS RETURNED FROM CUSTOMER CONTROL LOT (3009503) . CUSTOMER BATCH NUMBER (2222697) . SERUM NO. 12: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO. 16: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 AND REACTIVE MINIMAL AT 1:2. SERUM NO'S; 20: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:2 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 26 AND 31, LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1 TO 1.2 SERUM NO¿S 34: ALL LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1. THE SURFACE TEXTURE OF THE CARD TESTING AREA WAS EVALUATED AND IS SAME AS THE PREVIOUS ONE. NEW SUPPLIER WAS QUALIFIED IN OCTOBER 2020 SINCE PREVIOUS SUPPLIER NOTIFIED THAT THEY ARE NO LONGER PRODUCING THE WHITE BOARD TO MAKE THE CARDS. THE QUALIFICATION OF THE NEW SUPPLIER WAS COMPLETED WITH SATISFACTORY RESULTS. THE TEXTURE OR SURFACE FINISH CANNOT BE DETERMINED OR IDENTIFIED IN THE PHOTO PROVIDED. COMPLAINT UNCONFIRMED BASED ON VISUAL INSPECTION, SEROLOGY TEST AND BATCH RECORD REVIEW. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL 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 BD MACRO-VUE¿ RPR CARD TEST ARRIVED WITH A STRANGE COATING THEM AND APPEAR TO BE DIFFERENT THAN WHAT THEY NORMALLY RECEIVE AND IT IS CAUSING ISSUES WITH TESTING. THERE WERE NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY RECEIVED HAVE A STRANGE COATING ON THEM AND APPEAR TO BE DIFFERENT THAN THE CARDS THAT THEY USUALLY RECEIVE AND IT IS CAUSING ISSUES WITH THEIR TESTING. LOT NUMBER IS UNKNOWN. REQUESTING THIS INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST ARRIVED WITH A STRANGE COATING THEM AND APPEAR TO BE DIFFERENT THAN WHAT THEY NORMALLY RECEIVE AND IT IS CAUSING ISSUES WITH TESTING. THERE WERE NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY RECEIVED HAVE A STRANGE COATING ON THEM AND APPEAR TO BE DIFFERENT THAN THE CARDS THAT THEY USUALLY RECEIVE AND IT IS CAUSING ISSUES WITH THEIR TESTING. LOT NUMBER IS UNKNOWN. REQUESTING THIS INFORMATION FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658519 BD MACRO-VUE¿ RPR CARD TEST ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 275110 2222697

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown