BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCALIBUR¿ FLOW CYTOMETER

    MDR report key: 17379804 · Received July 24, 2023

    Report

    Report Number
    2916837-2023-00147
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    March 28, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903429752
    PMA / PMN Number
    K923790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.4 INITIAL REPORTER PHONE #:(B)(6). E.7 INITIAL REPORTER ADDR 1: (B)(6). G.6 PMA / 510(K)#: K923790, K973483. H.3. 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

    H.6: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00147 WAS SENT IN ERROR. IT HAS BEEN DETERMINED THAT THE ISSUE WAS RELATED TO A MISCONFIGURATION THAT WAS FIXED AND THERE WERE NO ERRORS IN FINAL RESULTS, THEREFORE, THIS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE RELATED TO A EVENT RATE ISSUE; VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION NO RESULTS INVOLVED, WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED. COULD YOU CLARIFY WHAT THE "UNEXPECTED RESULTS" WOULD BE? VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION WERE THE UNEXPECTED RESULTS WITH CONTROL SAMPLES OR WITH PATIENT SAMPLES? NO. RESULTS WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED, SO THE PATIENT WAS NOT TREATED BASED ON THE RESULT AND WAS NOT SUBJECTED TO HARM. IF PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. WAS THE PATIENT TREATED BASED ON THE OUTCOME? NO. WAS THERE ANY HARM TO THE PATIENT? NO. EQUIPMENT DID NOT ENABLE FL4 AT POWER UP, BEING NECESSARY TO ENABLE IT MANUALLY FOR CALIBRATION. HOWEVER, AFTER ACQUIRING THE SAMPLES THE RESULTS SHOWED UNEXPECTED RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE RELATED TO A EVENT RATE ISSUE; VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION NO RESULTS INVOLVED, WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED. - COULD YOU CLARIFY WHAT THE "UNEXPECTED RESULTS" WOULD BE? VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION - WERE THE UNEXPECTED RESULTS WITH CONTROL SAMPLES OR WITH PATIENT SAMPLES? NO RESULTS WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED, SO THE PATIENT WAS NOT TREATED BASED ON THE RESULT AND WAS NOT SUBJECTED TO HARM. - IF PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO - WAS THE PATIENT TREATED BASED ON THE OUTCOME? NO - WAS THERE ANY HARM TO THE PATIENT? NO EQUIPMENT DID NOT ENABLE FL4 AT POWER UP, BEING NECESSARY TO ENABLE IT MANUALLY FOR CALIBRATION. HOWEVER, AFTER ACQUIRING THE SAMPLES THE RESULTS SHOWED UNEXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370143 BD FACSCALIBUR¿ FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903429752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown