BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSPRESTO

    MDR report key: 11771185 · Received May 4, 2021

    Report

    Report Number
    2916837-2021-00218
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 8, 2021
    Report Date
    September 7, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00218 WAS SENT IN ERROR. THE CUSTOMER LATER CONFIRMED THAT THE FACSPRESTO DID NOT HAVE ISSUES THE ISSUE WAS DISCOVERED TO BE WITH ANOTHER HEMATOLOGY ANALYZER, THEREFORE, THE INSTRUMENT HAD NO REPORTED ERROR AND WOULD NOT BE REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING PATIENT SAMPLES WITH BD FACSPRESTO¿ ERRONEOUS HB RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT IS REPORTED TO GIVE WRONG HB RESULTS.

    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 FACSPRESTO¿ ERRONEOUS HB RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT IS REPORTED TO GIVE WRONG HB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670468 BD FACSPRESTO NA GKL BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1