BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACSLYRIC 3L12C INSTRUMENT CEIVD

    MDR report key: 12516345 · Received September 22, 2021

    Report

    Report Number
    2916837-2021-00378
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 30, 2021
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THE SET UP FAILURE IS A DESIGN FAILSAFE TO ALERT THE USER THAT THE DEVICE SHOULD BE RENDERED UNUSABLE AND IS UNLIKELY TO LEAD TO SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING FACSLYRIC 3L12C INSTRUMENT CEIVD. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT TODAYS INTERNAL CONTROLS FAILED BECAUSE OF TOO HIGH ABSOLUTE COUNTS ON LYMPHOCYTE POPULATIONS. THE SAME TUBE ANALYZED ON DIFFERENT INSTRUMENTS GAVE ACCEPTABLE RESULTS (WITHIN THE RANGE OF CUSTOMER'S CONTROL).

    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 THAT THERE WERE ERRONEOUS RESULTS WHILE USING FACSLYRIC 3L12C INSTRUMENT CEIVD. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT TODAYS INTERNAL CONTROLS FAILED BECAUSE OF TOO HIGH ABSOLUTE COUNTS ON LYMPHOCYTE POPULATIONS. THE SAME TUBE ANALYZED ON DIFFERENT INSTRUMENTS GAVE ACCEPTABLE RESULTS (WITHIN THE RANGE OF CUSTOMER'S CONTROL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414748 FACSLYRIC 3L12C INSTRUMENT CEIVD NA OYE NA

    Patients

    Seq Age Sex Outcome Treatment
    1