BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LWA

    MDR report key: 11959665 · Received June 8, 2021

    Report

    Report Number
    2916837-2021-00269
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    October 13, 2020
    Report Date
    June 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR# 2916837-2021-00269 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING PATIENT SAMPLES WITH BD FACS¿ LWA ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CARRYOVER WITH BLOOD FROM NORMAL DONOR. THE ROOT CAUSE OF CARRYOVER FAILURE APPEARS TO BE THE USE OF ¿PATIENT SAMPLES¿ FOR CARRYOVER TESTS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2: WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED WHILE TESTING PATIENT SAMPLES WITH BD FACS¿ LWA ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CARRYOVER WITH BLOOD FROM NORMAL DONOR. THE ROOT CAUSE OF CARRYOVER FAILURE APPEARS TO BE THE USE OF ¿PATIENT SAMPLES¿ FOR CARRYOVER TESTS. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NOT APPLICABLE. 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
    858248 BD FACS LWA STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1