BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1924705 · Received December 14, 2010

    Report

    Report Number
    2050012-2010-01594
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, THE CUSTOMER LOADED A TG CARTRIDGE, APPARENTLY WITHOUT PREPARING IT CORRECTLY BY TRANSFERRING THE REAGENT FROM COMPARTMENT C TO COMPARTMENT A. THE INSTRUMENT LOADED THE CARTRIDGE WITHOUT ALARMS. BECAUSE THE CUSTOMER IS USING WITHIN-LOT CALIBRATION, NO CALIBRATION WAS REQUIRED. NORMALLY THE CUSTOMER RUNS QC ON A NEW CARTRIDGE, BUT THEY FAILED TO DO SO IN THIS CASE. AT SOME POINT BETWEEN (B)(4) 2010 AND (B)(4) /2010 THE OLD CARTRIDGE WAS USED UP AND THE SYSTEM SWITCHED TO THE NEW ONE. QC WAS ON THE HIGHER LIMIT BUT STILL WITHIN THE RANGE, AND THE CUSTOMER USED THE NEW CARTRIDGE UNTIL (B)(4) 2010. DURING THIS PERIOD, AN UNKNOWN NUMBER OF PATIENTS' SAMPLES WERE RUN WITH INCORRECT RESULTS. THE MISTAKE WAS NOTICED QUICKLY AND THE RESULTS WERE CORRECTED. ON (B)(4) 2010, THE CUSTOMER DECIDED TO CALIBRATE BECAUSE QC WAS BAD. AT THIS TIME THEY FOUND OUT THAT TG REAGENT WAS NOT RECONSTITUTED, AND REPLACED THE CARTRIDGE. AFTER SOME INVESTIGATION THE CUSTOMER BELIEVES THAT THE CONCERNED REAGENT CARTRIDGE WAS RECONSTITUTED WRONG. THE REAGENT C WAS MOVED TO THE WRONG SECTION OF THE CARTRIDGE (I.E., TRANSFERRED FROM C TO B INSTEAD OF A). THIS WOULD EXPLAIN THE FACT THAT THE LEVEL SENSE DID NOT REACT. A BCI FIELD SERVICE ENGINEER VISITED THE SITE, BUT COULD NOT REPRODUCE THE PROBLEM. EACH LOADING OF A NON-RECONSTITUTED CARTRIDGE WAS REJECTED FROM THE INSTRUMENT. A USER ERROR IS THE LIKELY ROOT CAUSE FOR THIS EVENT, BUT IT CAN NOT BE CONFIRMED BECAUSE ALL CONCERNED CARTRIDGES ARE NOW REMOVED AND DISCARDED TO WASTE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INCORRECT TRIGLYCERIDES (TG) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THE PATIENT TREATMENTS WERE AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other