BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LEUCOCOUNT¿

    MDR report key: 17477582 · Received August 8, 2023

    Report

    Report Number
    2916837-2023-00159
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 10, 2023
    Report Date
    February 28, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903410033
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: BK000035. G.5. PMA / 510(K)#: BK000036. 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 AND/OR ADDITIONAL INFORMATION: ANNEX F CODE WAS CORRECTED TO F26 REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES - SAN JOSE REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR MANUFACTURING LOCATION: BECTON DICKINSON AND COMPANY BD BIOSCIENCES- SAN JOSE MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR H.6: BD ACKNOWLEDGES THE CUSTOMER¿S EXPERIENCE REGARDING THE INDICATED FAILURE MODE OF INCREASING DEBRIS WHICH STARTED TO IMPACT THE BEAD COUNT WITH THE REPORTED CUSTOMER EVENT ON BD LEUCOCOUNT COMBO RBC/PLT CONTROL KIT (341003-LC0723). BASED ON THE INVESTIGATION RESULTS CONDUCTED AND PROVIDED BY THE SUPPLIER ON RETAIN SAMPLE: THE DATA IS IN RANGE. PRODUCT HISTORY REVIEW AS REPORTED BY THE SUPPLIER, THE PRODUCT WAS WITHIN SPECIFICATION LIMITS WHEN RELEASED. THE REPORTED ISSUE WAS NOT CONFIRMED. NO SERIOUS INJURY, DEATH, ERRONEOUS RESULTS, OR TREATMENT CHANGE WERE REPORTED THAT AFFECT A PATIENT SAFETY. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS PRODUCT AND REPORTED FAILURES IN ORDER TO IDENTIFY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER/ CONTAMINATION IN THE REAGENT DURING USE WITH THE BD LEUCOCOUNT¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER EACH THERMO CYCLE USE OF THE COMBO CONTROL, DEBRIS IS INCREASING, WHICH IS STARTING TO IMPACT THE BEAD COUNT. CUSTOMER WOULD LIKE TO INVESTIGATE THE ISSUE. BOX WAS OPENED LAST WEEK AND HAS GONE THROUGH 3 THERMAL CYCLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER/ CONTAMINATION IN THE REAGENT DURING USE WITH THE BD LEUCOCOUNT¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER EACH THERMO CYCLE USE OF THE COMBO CONTROL, DEBRIS IS INCREASING, WHICH IS STARTING TO IMPACT THE BEAD COUNT. CUSTOMER WOULD LIKE TO INVESTIGATE THE ISSUE. BOX WAS OPENED LAST WEEK AND HAS GONE THROUGH 3 THERMAL CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261407 BD LEUCOCOUNT¿ COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES LC0723 00382903410033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown