BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL COAGULASE PLASMA, RABBIT WITH EDTA

    MDR report key: 12248718 · Received July 29, 2021

    Report

    Report Number
    1025402-2021-00006
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 27, 2021
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    JTL
    UDI-DI
    30382902408278
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: RETURNS WERE EXPECTED BUT NONE WERE RECEIVED FOR THIS COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE TEST PROCEDURE AND EQUIPMENT BEING USED BY THE CUSTOMER, BUT NONE WAS PROVIDED. TO INVESTIGATE THE COMPLAINT ON CATALOG NUMBER 240827 BATCH 0275787, A RETAINED SAMPLE OF THE COMPLAINT LOT WAS TESTED, ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, WITH AVAILABLE CULTURE STRAINS OF STAPHYLOCOCCUS AUREUS. BASED ON THE COMPLAINT NOTES, THE CUSTOMER IS USING PLATE-GROWN CULTURES FOR TESTING. THEREFORE, TESTING OF THE LOT WAS PERFORMED USING COLONIES OF EACH STRAIN OF STAPHYLOCOCCUS AUREUS PICKED DIRECTLY FROM AGAR PLATES. TO TEST THE LOT, TEST TUBES CONTAINING 0.5 ML OF THE COAGULASE PLASMA WERE PREPARED, AND 3 OR MORE COLONIES, UP TO A 1 ¿L LOOP FULL, WERE PICKED AND ADDED TO EACH TUBE. ALL TUBES WERE INCUBATED AT 37°C AND READ EVERY TWO HOURS, UP TO 6 HOURS. RESULTS WERE AS FOLLOWS: 2+ TO 4+ CLOTS WERE OBSERVED AT 2 HOURS AND 4+ CLOTS WERE OBSERVED AT 4 AND 6 HOURS WITH ALL STRAINS TESTED; THE TEST WAS DISCONTINUED AFTER 6 HOURS INCUBATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON THIS TESTING. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY. NO QUALITY NOTIFICATIONS WERE ISSUED FOR THE PRODUCT BATCH. COMPLAINTS FOR THE PRODUCT WERE REVIEWED. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS PRODUCT IN THE THREE-YEAR PERIOD REVIEWED; BD QUALITY WILL CONTINUE TO MONITOR CLOSELY FOR TRENDS ASSOCIATED WITH FALSE NEGATIVE RESULTS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 49 BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA 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 PATIENT STAPH AUREUS ISOLATES ARE NOT CLOTTING WITH USE OF 240827 LOT 0275787. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147384 BD BBL COAGULASE PLASMA, RABBIT WITH EDTA PLASMA, COAGULASE, HUMAN, HORSE AND RABBIT JTL LEE LABORATORIES, INC. 240827 0275787 30382902408278

    Patients

    Seq Age Sex Outcome Treatment
    1