BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    MDR report key: 13765801 · Received March 15, 2022

    Report

    Report Number
    2647876-2022-00063
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    November 1, 2021
    Report Date
    March 31, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GMQ
    UDI-DI
    30382902703335
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE OF EVENT IS UNKNOWN. INFORMATION PROVIDED: "THIS TEST WAS DONE IN (B)(6) 2021" 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

    H6: INVESTIGATION SUMMARY 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 CGG. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, DISCREPANT RESULTS WERE OBTAINED. THE RESULT WAS POSITIVE WHILE CONFIRMATORY TESTING WITH A COMPETITOR'S REAGENT PRODUCED A NEGATIVE RESULT. POSITIVE RESULT WAS REPORTED OUT; THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IN (B)(6) RECEIVED A (1 : 32) TITER FOR ONE OF THE PATIENT SAMPLES WHILE (B)(6) DID THE RPR TEST FOR THIS PATIENT USING COMPETITOR'S REAGENTS, AND OBTAINED A TITER OF (1 : 1); PATIENT RESULT WAS REPORTED AS (1 : 32);

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, DISCREPANT RESULTS WERE OBTAINED. THE RESULT WAS POSITIVE WHILE CONFIRMATORY TESTING WITH A COMPETITOR'S REAGENT PRODUCED A NEGATIVE RESULT. POSITIVE RESULT WAS REPORTED OUT; THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IN CLINICAL LABS OF HAWAII RECEIVED A (1 : 32) TITER FOR ONE OF THE PATIENT SAMPLES WHILE DOH OF HAWAII DID THE RPR TEST FOR THIS PATIENT USING COMPETITOR'S REAGENTS, AND OBTAINED A TITER OF (1 : 1); PATIENT RESULT WAS REPORTED AS (1 : 32);

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40820 BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION ANTIGENS, NONTREPONEMAL, ALL GMQ BECTON DICKINSON CARIBE LTD. 270333 1123493 30382902703335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown