BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LWA

    MDR report key: 18066619 · Received November 3, 2023

    Report

    Report Number
    2916837-2023-00214
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 23, 2023
    Report Date
    March 19, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: G.1. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES G.2. REPORTING OFFICE CONTACT: (B)(6). INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE UNEXPECTED RESULTS WAS DETERMINED TO BE WORN OUT CELL WASH ASSEMBLY AND V3. THE FSE REPLACED THE PARTS AND AFTER SUBSEQUENT TESTING THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE DIAGNOSED OR TREATED BASED ON ANY UNEXPECTED RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. 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

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 1: (B)(6). 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 WHILE USING THE BD FACS¿ LWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE) 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? NOT APPLICABLE 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? THEY RERAN SAMPLE ON A DIFFERENT INSTRUMENT WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? THERE WAS NO CARRY OVER IT WAS REPORTED BY THE CUSTOMER THAT SYSTEM IS HAVING PROBLEMS WASHING SAMPLES ON SPECIFIC PROGRAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED WHILE USING THE BD FACS¿ LWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE). 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? NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? THEY RERAN SAMPLE ON A DIFFERENT INSTRUMENT. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? THERE WAS NO CARRY OVER. IT WAS REPORTED BY THE CUSTOMER THAT SYSTEM IS HAVING PROBLEMS WASHING SAMPLES ON SPECIFIC PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221566 BD FACS¿ LWA STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown