BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTITEST¿

    MDR report key: 17260465 · Received July 5, 2023

    Report

    Report Number
    2916837-2023-00132
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    December 1, 2022
    Report Date
    July 14, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K060375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00132 WAS SENT IN ERROR. CUSTOMER HAS CONFIRMED THAT THE PRODUCT REPORTED TO HAVE MALFUNCTIONED WAS NOT A PRODUCT MANUFACTURED BY BD.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. 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 · 0

    IT WAS REPORTED THAT BD MULTITEST¿ TUBES ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. THERE ARE TWO REASONS WHY I AM INVESTIGATING THE TBNK RESULTS: 1) WE HAVE HAD NUMEROUS RCPA SURVEYS OVER THE PAST COUPLE OF YEARS WHERE SOME OF OUR ABSOLUTE VALUES ARE TOO HIGH (ESPECIALLY CD8, AND NK CELLS). 2) WE HAVE SEEN A TREND WITH OUR STRECK CD4 LOW CONTROL WHERE THERE CD4 ABSOLUTE COUNTS HAVE BEEN CONSISTENTLY UNDER THE MEAN VALUE SINCE DECEMBER 2022, AND IT IS CONSISTENT ON BOTH CANTOS.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MULTITEST¿ TUBES ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES THERE ARE TWO REASONS WHY I AM INVESTIGATING THE TBNK RESULTS: 1) WE HAVE HAD NUMEROUS RCPA SURVEYS OVER THE PAST COUPLE OF YEARS WHERE SOME OF OUR ABSOLUTE VALUES ARE TOO HIGH (ESPECIALLY CD8, AND NK CELLS). 2) WE HAVE SEEN A TREND WITH OUR STRECK CD4 LOW CONTROL WHERE THERE CD4 ABSOLUTE COUNTS HAVE BEEN CONSISTENTLY UNDER THE MEAN VALUE SINCE (B)(6) 2022, AND IT IS CONSISTENT ON BOTH CANTOS.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989608 BD MULTITEST¿ COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337166 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other