BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2261499 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04893
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) WENT TO THE LABORATORY TO INVESTIGATE AND TRY TO DETERMINE THE CAUSE OF THE LOW CALC RESULTS. THE FSE ONLY FOUND THE WRONG PN FOR CO2 ACID REAGENT IN THE LAB. ALL OF THE OTHER ISE REAGENTS WERE CORRECT. THE ENGINEER REQUESTED EXAMPLES OF THE HIGH CALC RESULTS AND THE CORRECTED RESULTS. THIS LAB IS PAPERLESS AND DOES NOT HAVE RESULT PRINTOUTS. THE RESULTS WERE NOT PROVIDED. THE CO2 ACID REAGENT IS NOT A COMPONENT IN CALC DETERMINATION. A ROOT CAUSE FOR THE ERRONEOUS CALC RESULTS HAS NOT BEEN IDENTIFIED. THE APPROPRIATE HOTLINE MANAGERS HAVE BEEN NOTIFIED OF THIS CF AND ACTIONS HAVE BEEN TAKEN TO PROVIDE THE CORRECT INFORMATION TO THE HOTLINE PERSON WHO PROVIDED INCORRECT INFORMATION REGARDING THE CO2 ACID REAGENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 3 OF 35 REPORTED BY THIS CUSTOMER .

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY ELEVATED CALCIUM (CALC) RESULTS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT, BUT THERE HAVE BEEN NO REPORTS OF DEATH OR SERIOUS INJURY. THE CUSTOMER HAD RECEIVED CARBON DIOXIDE (CO2) ACID REAGENT FOR THE CX ANALYZER INSTEAD OF CO2 ACID REGENT FOR THE DXC ANALYZER. THE CUSTOMER CALLED HOTLINE TO ASK IF THE CO2 ACID REAGENTS WERE INTERCHANGEABLE AND WAS INCORRECTLY TOLD THEY WERE. THE CX REAGENT WAS LOADED ON THE ANALYZER. THE ISE SYSTEM CALIBRATED AND ALL QUALITY CONTROL (QC) RESULTS WERE WITHIN THE ESTABLISHED RANGES. LATER IN THE DAY, THE CLINIC STAFF CALLED THE LAB TO REPORT THAT ALL OF THE CALC RESULTS REPORTED THAT DAY WERE ABOVE THE REFERENCE RANGES. A CALC QC WAS RUN AND THE RESULTS WERE >2 STANDARD DEVIATIONS HIGH. THE CORRECT CO2 ACID REAGENT WAS LOADED ON THE ANALYZER AND THE ISE SYSTEM PRIMED, CALIBRATED AND QC RUN. ALL SAMPLES RUN FOR CALC WERE REPEATED AND ALL OF THE PREVIOUSLY HIGH CALC RESULTS WERE WITHIN THE REFERENCE RANGE. AMENDED REPORTS WERE ISSUED ON ABOUT 35 RESULTS. THIS IS REPORT 3 OF 35 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PATIENT 3 OF 35 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK