BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTI-CHECK¿

    MDR report key: 16876777 · Received May 5, 2023

    Report

    Report Number
    2916837-2023-00103
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    May 2, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903409112
    PMA / PMN Number
    K961610
    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.7 PMA / 510(K)#K961610, K982231. B3: DATE OF EVENT IS UNKNOWN. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00103 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAY BATCH BM0523N ASSAY VALUES SHEET IS MISSING VALUES FOR ALL MARKERS EXCEPT TBNK. CANNOT BE USED TO VALIDATE LABORATORY ANTIBODY PERFORMANCE, HENCE UNABLE TO VALIDATE RESULTS FOR PATIENT REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAY BATCH BM0523N ASSAY VALUES SHEET IS MISSING VALUES FOR ALL MARKERS EXCEPT TBNK. CANNOT BE USED TO VALIDATE LABORATORY ANTIBODY PERFORMANCE, HENCE UNABLE TO VALIDATE RESULTS FOR PATIENT REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212697 BD MULTI-CHECK¿ NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 340911 BM0523N 00382903409112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown