BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 11833025 · Received May 17, 2021

    Report

    Report Number
    2916837-2021-00238
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#(B)(4) IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH A BD FACSLYRIC¿ THERE WAS AN INCREASE IN ABSOLUTE COUNT VALUES VERSUS TESTING PERFORMED ON FACSCANTO. THERE WAS NO REPORT OF PATIENT IMPACT. OBSERVED INCREASING ABSOLUTE COUNT VALUES (CELLS/UL) ON TBNK ON FACSLYRIC INSTRUMENTS DURING 2021. MULTICHECK CONTROL VALUES FINALLY OUT-OF-RANGE IN (B)(6) 2021 ON FACSLYRIC. IN COMPARISON THE MULTICHECK CONTROL VALUES ON FACSCANTO ARE PERFECT DURING THE SAME PERIOD. DURING 2020 THE CANTO AND FACSLYRIC GAVE SIMILAR RESULTS. ALSO THE PATIENT SAMPLES DIFFER BETWEEN CANTO AND LYRIC, STARTING(B)(6)2021(HIGHER VALUES ON FACSLYRIC).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH A BD FACSLYRIC¿ THERE WAS AN INCREASE IN ABSOLUTE COUNT VALUES VERSUS TESTING PERFORMED ON FACSCANTO. THERE WAS NO REPORT OF PATIENT IMPACT. OBSERVED INCREASING ABSOLUTE COUNT VALUES (CELLS/UL) ON TBNK ON FACSLYRIC INSTRUMENTS DURING 2021. MULTICHECK CONTROL VALUES FINALLY OUT-OF-RANGE IN (B)(6) 2021 ON FACSLYRIC. IN COMPARISON THE MULTICHECK CONTROL VALUES ON FACSCANTO ARE PERFECT DURING THE SAME PERIOD. DURING 2020 THE CANTO AND FACSLYRIC GAVE SIMILAR RESULTS. ALSO THE PATIENT SAMPLES DIFFER BETWEEN CANTO AND LYRIC, STARTING (B)(6) 2021 (HIGHER VALUES ON FACSLYRIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735280 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1