BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ SAMPLE PREP ASSISTANT III

    MDR report key: 18130721 · Received November 14, 2023

    Report

    Report Number
    2916837-2023-00219
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 16, 2023
    Report Date
    March 16, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K131301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(6). G1. REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE REPORTED 'ACCURACY ISSUE' WAS NOT CONFIRMED. THE POTENTIAL CAUSE WAS NOT DETERMINED. THE FSE CHECKED THE SYSTEM OPERATION, VERIFIED SAMPLE VOLUME WITH A&P TEST. THE SYSTEM WAS INITIALIZED AND FUNCTIONS PROPERLY WITHOUT ERROR. 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

    D2A:COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. 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 BD FACS¿ SAMPLE PREP ASSISTANT III HAS ACCURACY ISSUES OCCURRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCURACY ISSUES. THEY HAVE REBOOTED THE INSTRUMENT AND COMPUTER. NO CHANGE 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III HAS ACCURACY ISSUES OCCURRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCURACY ISSUES. THEY HAVE REBOOTED THE INSTRUMENT AND COMPUTER. NO CHANGE 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974039 BD FACS¿ SAMPLE PREP ASSISTANT III SEE H.10 PER BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906472052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown