BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2463121 · Received February 21, 2012

    Report

    Report Number
    2050012-2012-00510
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS UNABLE TO CONFIRM THE COMPLAINT. CUSTOMER REFUSED SERVICE. CUSTOMER CLAIMED THE REAGENT CAUSED THE ERRONEOUS RESULTS. HOWEVER, THERE IS NO INFORMATION THAT SUGGESTS THE REAGENT CAUSED THE ISSUE. CUSTOMER REPORTED THAT QUALITY CONTROL WAS RUNNING ON THE LOW SIDE PRIOR TO THE REPLACEMENT OF THE REAGENT. RECALIBRATION OF THE INSTRUMENT COULD HAVE RESOLVED THE ISSUE. REAGENT INFORMATION: REAGENT NAME: SYNCHRON LX/DXC ISE ELECTROLYTE BUFFER. REAGENT CATALOG NUMBER: A28945. REAGENT LOT NUMBER: UNKNOWN. REAGENT DATE OF MANUFACTURE: UNKNOWN. REAGENT EXPIRATION DATE: UNKNOWN. REAGENT 510K NUMBER: K965240. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED LOW SODIUM AND CHLORIDE RESULTS ON TEN PATIENT SAMPLES. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE 10 POINTS LOWER. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THEY CHANGED THE ION SELECTIVE ELECTRODE (ISE) BUFFER REAGENT BECAUSE THE REAGENT HAD A YELLOWISH COLOR. CUSTOMER REPORTED THAT ELECTROLYTES WERE CALIBRATED AND CONTROLS CHECKED WITH THE NEW REAGENT LOT. CUSTOMER REPORTED THAT THEY THEN RERAN THE PREVIOUSLY RAN SAMPLES AND AMENDED EIGHT RESULTS. CUSTOMER REPORTED THAT THEY BELIEVE QUALITY CONTROL WAS ON THE LOW SIDE PRIOR TO THE REPLACEMENT OF THE REAGENT. BEC CUSTOMER TECHNICAL SUPPORT EXPLAINED TO THE CUSTOMER THAT PRESERVATIVE IN THE REAGENT CAN DEEPEN THE COLOR OF THE REAGENT, BUT SHOULD NOT ADVERSELY AFFECT REAGENT PERFORMANCE. CUSTOMER REFUSED SERVICE ON THE INSTRUMENT. CUSTOMER REPORTED THAT NEW REAGENT RESOLVED THE ISSUE. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE REAGENT THAT HAD THE YELLOWISH COLOR. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1