BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 17761931 · Received September 16, 2023

    Report

    Report Number
    2916837-2023-00181
    Event Type
    Malfunction
    Date Received
    September 16, 2023
    Date of Event
    September 5, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE#: (B)(6). 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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. CUSTOMER REPORTED, ¿CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. " FSE ALSO CONFIRMED ONSITE THAT CARRYOVER WAS (B)(4) AND INSTRUMENT WORKS WITHIN SPECIFICATION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2023-09-08: ADDITIONAL INFORMATION BASED ON FSE¿S EMAIL: WE ANALYZED TWO OF THE THREE ¿PIRS¿- LWAS: (B)(6), (B)(4), SN (B)(6), (B)(4). ALSO LWA WITH SN (B)(6), (B)(4) WAS ANALYZED AS A REFERENCE FOR CARRYOVER. IT WAS NOT POSSIBLE TO CHECK ALSO LWA (B)(6), IT SHOULD BE TESTED. ALL THREE LWAS WERE CHECKED FOR CARRY OVER AND ALSO FOR CELL LOSS, USING STAINED WHOLE BLOOD. CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. SELECTIVE CELL LOSS COULD NOT BE DETECTED WITH LYSED WHOLE BLOOD IN ALL THREE SYSTEMS. A KAPPA-APC POSITIVE POPULATION WAS FOUND IN A SAMPLE TUBE DURING ACQUISITION, BUT SAMPLE HAS NOT SUCH POPULATION (SEEN IN REPEATED PREPARATION) PIR3011629.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2023-09-08: ADDITIONAL INFORMATION BASED ON FSE¿S EMAIL: WE ANALYZED TWO OF THE THREE ¿PIRS¿- LWAS: (B)(6) [(B)(4)], SN (B)(6) [8840757]. ALSO LWA WITH SN (B)(6) [(B)(4)] WAS ANALYZED AS A REFERENCE FOR CARRYOVER. IT WAS NOT POSSIBLE TO CHECK ALSO LWA (B)(6), IT SHOULD BE TESTED. ALL THREE LWAS WERE CHECKED FOR CARRY OVER AND ALSO FOR CELL LOSS, USING STAINED WHOLE BLOOD. CARRYOVER OFF ALL CHECKED SYSTEMS WAS LOWER THAN 50 PPM, MEET SPECIFICATION. SELECTIVE CELL LOSS COULD NOT BE DETECTED WITH LYSED WHOLE BLOOD IN ALL THREE SYSTEMS. A KAPPA-APC POSITIVE POPULATION WAS FOUND IN A SAMPLE TUBE DURING ACQUISITION, BUT SAMPLE HAS NOT SUCH POPULATION (SEEN IN REPEATED PREPARATION) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303516 BD FACS¿ LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown