BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA

    MDR report key: 12913619 · Received December 1, 2021

    Report

    Report Number
    1025402-2021-00007
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 2, 2021
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    JTL
    UDI-DI
    30382902408261
    PMA / PMN Number
    PREAMENDMENT
    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

    INVESTIGATION SUMMARY: RETURNED KITS OF BOTH LOTS WERE RECEIVED FOR THIS COMPLAINT; TWO KITS OF LOT 1084793 AND 1 KIT OF LOT 1182949 WERE RECEIVED IN THE RETURN. BASED ON THE COMPLAINT NOTES AND PHOTO PROVIDED, THE CUSTOMER IS OBSERVING AUTOAGGLUTINATION AFTER PREPARATION OF THE TEST TUBES OR DURING TESTING. NO BACTERIAL CULTURE WAS MENTIONED, THEREFORE THE COMPLAINT LOTS WERE TESTED WITH NOTHING ADDED TO EACH TUBE OTHER THAN THE COAGULASE PLASMA. FOR THIS TESTING, TWO RETAINED SAMPLES FROM EACH LOT WERE TESTED ALONG WITH TWO SAMPLES FROM EACH OF THE RETURNED KITS FOR A TOTAL OF (B)(4) SAMPLES TESTED (6 OF LOT 1084793 AND 4 OF LOT 1182949); ALL SAMPLES WERE REHYDRATED WITH AUTOCLAVED DEIONIZED WATER. TO TEST EACH SAMPLE, TEST TUBES CONTAINING 0.5 ML OF THE COAGULASE PLASMA ONLY WERE PREPARED. ALL TUBES WERE INCUBATED AT 37°C AND READ EVERY TWO HOURS, UP TO 6 HOURS. INCUBATION CONTINUED TO 24 HOURS WHEN THE FINAL READING WAS COMPLETED. RESULTS WERE AS FOLLOWS: (B)(4) SAMPLES (2 RETAIN AND 4 RETURN) OF LOT 1084793 - NO CLOTTING OR AGGLUTINATION WAS OBSERVED AT ANY OF THE READINGS (B)(4) SAMPLES (2 RETAIN AND 2 RETURN) OF LOT 1182949 - NO CLOTTING OR AGGLUTINATION WAS OBSERVED AT ANY OF THE READINGS THE COMPLAINT WAS NOT CONFIRMED BASED ON THIS TESTING. THE BATCH HISTORY RECORDS FOR THE LOTS WERE REVIEWED AND FOUND SATISFACTORY. 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 POSITIVE RESULTS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1182949. MEDICAL DEVICE EXPIRATION DATE: 06/23/2024. DEVICE MANUFACTURE DATE: 07/01/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA A PERFORMANCE ISSUE RESULTING IN AUTO-AGGLUTINATION OCCURRED. 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: D. AT WHAT TEMPERATURE WAS THE PRODUCT SHIPPED TO YOU? ¿ ROOM TEMPERATURE HOW DID YOU STORE RECONSTITUTED PLASMA? ¿ USING DEIONIZED WATER IS THIS ISSUE OCCURRING WITH PLASMA FROM BOTH LOTS? - YES   C. CUSTOMER PROBLEM: COAG PLASMA 240826 AUTO-AGGLUTINATION PHOTOS OR RETURNS REQUESTED? 1 PHOTO IS ATTACHED, REQUESTED PHOTOS OF AFFECTED PRODUCT WITH LOT NUMBER IT WAS REPORTED THAT COAG PLASMA 240826 AUTO-AGGLUTINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA A PERFORMANCE ISSUE RESULTING IN AUTO-AGGLUTINATION OCCURRED. 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: D-AT WHAT TEMPERATURE WAS THE PRODUCT SHIPPED TO YOU?  ROOM TEMPERATURE. HOW DID YOU STORE RECONSTITUTED PLASMA?  USING DEIONIZED WATER. IS THIS ISSUE OCCURRING WITH PLASMA FROM BOTH LOTS?  YES.   C¿CUSTOMER PROBLEM: COAG PLASMA 240826 AUTO-AGGLUTINATION. PHOTOS OR RETURNS REQUESTED? 1 PHOTO IS ATTACHED, REQUESTED PHOTOS OF AFFECTED PRODUCT WITH LOT NUMBER . IT WAS REPORTED THAT COAG PLASMA 240826 AUTO-AGGLUTINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811522 BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA COAGULASE PLASMA JTL LEE LABORATORIES, INC. 240826 1084793 30382902408261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown