BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTITEST¿

    MDR report key: 18679416 · Received February 9, 2024

    Report

    Report Number
    2916837-2024-00015
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 12, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382906629678
    PMA / PMN Number
    SEE H.10
    Removal / Correction Number
    RES# 94830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE (NON-SPECIFIC STAINING CREATING UNUSUAL STAINING PATTERNS FOR CD4+CD+8 POPULATIONS) WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DATA PROVIDED BY CUSTOMER WAS REVIEWED. RETAIN TESTING RESULTS SHOWED THE PRESENCE OF A NON-SPECIFIC STAINING. POTENTIAL CAUSE IS DETERMINED TO BE MANUFACTURING RELATED. ADDITIONAL CONTROLS HAVE BEEN PUT IN PLACE IN THE MANUFACTURING STAGE SPECIFIC TO THE SUPPLIED COMPONENT. CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ROOT CAUSE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: K090967. G.5. PMA / 510(K)#: K170974. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH BD MULTITEST IVD REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC, CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH BD MULTITEST IVD REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC, CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338921 BD MULTITEST¿ COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 69761 00382906629678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown