BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD

    MDR report key: 18040288 · Received October 31, 2023

    Report

    Report Number
    2916837-2023-00210
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 10, 2023
    Report Date
    July 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903389605
    PMA / PMN Number
    K062087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131 G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF A WASTE TANK FULL ERROR CODE WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR A WASTE TANK FULL ERROR WAS DUE TO A WORN CABLE WASTE STUB. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD WASTE TANK FULL ERROR OCCURRED WHILE RUNNING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE TANK FULL ERROR ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?: (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.):YES. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE?: (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD WASTE TANK FULL ERROR OCCURRED WHILE RUNNING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE TANK FULL ERROR. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.):YES. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226400 BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903389605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown