BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    MDR report key: 13742056 · Received March 12, 2022

    Report

    Report Number
    2647876-2022-00062
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    30382902703090
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: RETENTION SAMPLES: SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY. CONTROL LOT (1335592). CUSTOMER BATCH NUMBER (1123493). SERUM NO. 11: 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; 17: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:2 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 29, 32, 34 ALL LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1 TO 1:2. SERUM NO¿S. 3,7,10: ALL LOTS SHOWED NEGATIVE RESULTS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW. NO RETURNED GOODS RECEIVED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, 14 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY GG ENZYME AMINO ASSAY TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING FALSE POSITIVE RPR TEST. CUSTOMER EXPLAINED THAT MULTIPLE TECH HAVE RUN THE TEST THEY USED GG ENZYME AMINO ASSAY AS CONFIRMATORY. 14 FP HAVE BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, 14 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY GG ENZYME AMINO ASSAY TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING FALSE POSITIVE RPR TEST. CUSTOMER EXPLAINED THAT MULTIPLE TECH HAVE RUN THE TEST THEY USED GG ENZYME AMINO ASSAY AS CONFIRMATORY. 14 FP HAVE BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071590 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