BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TRUCOUNT

    MDR report key: 23804402 · Received December 15, 2025

    Report

    Report Number
    3008352382-2025-00004
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    June 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BD CARIBE, LTD
    Product Code
    GKZ
    UDI-DI
    00382906630285
    PMA / PMN Number
    K970836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HIGH BEAD COUNT IN BD TRUCOUNT¿ TUBES WAS CONFIRMED. CUSTOMER-PROVIDED DATA SUPPORTED THE COMPLAINT CONDITION, ALTHOUGH THE ISSUE COULD NOT BE REPLICATED DURING INTERNAL TESTING OF RETAIN SAMPLES. INVESTIGATION ACTIVITIES PERFORMED: RETURNED SAMPLE/DATA: NO PHYSICAL SAMPLE WAS RETURNED; HOWEVER, CUSTOMER PROVIDED DATA CONFIRMED HIGH BEAD COUNT THAN EXPECTED. RETAIN SAMPLE TESTING: TESTING ON RETAIN SAMPLES FOR LOT 24328 SHOWED A BEAD COUNT OF (B)(4), WHICH IS WITHIN EXPECTED VARIANCE AND DID NOT REPLICATE THE REPORTED CONDITION. DEVICE HISTORY REVIEW (DHR): BATCH 24328 WAS REVIEWED. MANUFACTURING COMPLIED WITH ALL SPECIFICATIONS. PELLET LOT 4191214 PASSED INCOMING INSPECTION WITH A MEAN BEAD COUNT OF (B)(4) BEADS PER PELLET. RISK REVIEW: EXISTING RISK CONTROLS ADDRESS BEAD VARIABILITY; HAZARD IDENTIFIED AS POTENTIAL FOR INACCURATE RESULTS. THE POTENTIAL CAUSE AND/OR RESOLUTION COULD NOT BE DETERMINED BECAUSE THE CONDITION COULD NOT BE REPLICATED DURING RETAIN SAMPLE TESTING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD TRUCOUNT¿ TUBES, ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT WERE REPORTED TO A CLINICIAN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIABLE COUNTING OF BEADS IN THE TRUCOUNT TUBE. IT WAS REPORTED THAT QUANTIFICATION OF LYMPHOCYTES, COUNTED ON FACS LYRIC FOR 5 MINUTES. WE EXPECTED ABOUT 20,000 BEADS BUT GOT 81,000 BEADS¿FOUR TIMES TOO MANY BEADS. THE SAMPLE WAS SET UP AGAIN, AND THE RESULT WAS AS EXPECTED. THIS WAS DISCOVERED IN A SAMPLE THAT WAS SET UP TO BE COUNTED FOR 5 MINUTES, WHICH MADE IT EASIER TO DETECT SINCE THE BEAD COUNT WAS SO HIGH. HOWEVER, WE HAVE SEEN THIS PROBLEM A COUPLE OF TIMES BEFORE. ONE OF THESE WAS DISCOVERED WHEN THE REQUESTER CALLED AND QUESTIONED THE RESULTS WE HAD ISSUED; THEY WERE LOWER THAN WHAT THE REQUESTER EXPECTED. UPON REANALYSIS, THE ANSWER WAS MORE AS EXPECTED, AND IT TURNED OUT THERE WERE TOO MANY BEADS IN THE FIRST RUN. THERE IS A SIGNIFICANT UNCERTAINTY HERE REGARDING HOW OFTEN THIS MAY HAVE HAPPENED WITHOUT BEING DETECTED. IT¿S NOT LIKE WE ALWAYS HAVE PREVIOUS TEST RESULTS TO COMPARE WITH. WHEN DID THE INCIDENT OCCUR? - DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD TRUCOUNT¿ TUBES, ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT WERE REPORTED TO A CLINICIAN. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIABLE COUNTING OF BEADS IN THE TRUCOUNT TUBE. IT WAS REPORTED THAT QUANTIFICATION OF LYMPHOCYTES, COUNTED ON FACS LYRIC FOR 5 MINUTES. WE EXPECTED ABOUT 20,000 BEADS BUT GOT 81,000 BEADS¿FOUR TIMES TOO MANY BEADS. THE SAMPLE WAS SET UP AGAIN, AND THE RESULT WAS AS EXPECTED (SEE ATTACHED FILE ON ATG PATIENT FROM JULY 13). THIS WAS DISCOVERED IN A SAMPLE THAT WAS SET UP TO BE COUNTED FOR 5 MINUTES, WHICH MADE IT EASIER TO DETECT SINCE THE BEAD COUNT WAS SO HIGH. HOWEVER, WE HAVE SEEN THIS PROBLEM A COUPLE OF TIMES BEFORE. ONE OF THESE WAS DISCOVERED WHEN THE REQUESTER CALLED AND QUESTIONED THE RESULTS WE HAD ISSUED; THEY WERE LOWER THAN WHAT THE REQUESTER EXPECTED. UPON REANALYSIS, THE ANSWER WAS MORE AS EXPECTED, AND IT TURNED OUT THERE WERE TOO MANY BEADS IN THE FIRST RUN (SEE ATTACHED PLOT FROM JUNE 3). THERE IS A SIGNIFICANT UNCERTAINTY HERE REGARDING HOW OFTEN THIS MAY HAVE HAPPENED WITHOUT BEING DETECTED. IT¿S NOT LIKE WE ALWAYS HAVE PREVIOUS TEST RESULTS TO COMPARE WITH. WHEN DID THE INCIDENT OCCUR? - DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106667 BD TRUCOUNT COUNTER, DIFFERENTIAL CELL GKZ BD CARIBE, LTD UNKNOWN 00382906630285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown