BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2046470 · Received April 8, 2011

    Report

    Report Number
    2050012-2011-00989
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE TYPE FOR THIS ASSAY IS RANDOM URINE. NO SAMPLE ISSUES WERE NOTED. PER CUSTOMER, QC HAS BEEN WITHIN RANGE. NO SYSTEM ERRORS WERE NOTED. BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: INSPECTED INSTRUMENT AND FOUND CARTRIDGE CHEMISTRY (CC) SAMPLE MIXER ASSEMBLY HAD A WORN TIP. REPLACED CC SAMPLE AND REAGENT MIXER ASSEMBLY AND VERIFIED ALIGNMENTS. REPLACED DEGASSER FILTER AND CC SAMPLE WASH COLLAR. VERIFIED WASH DELIVERY INSIDE MIXER WASH CUPS FOR SAMPLE AND REAGENT. VERIFIED THAT DELIVERY OF WATER DURING ONE PRIME CYCLE FOR CC SAMPLE PROBE IS EXPECTED VALUE OF 35ML. VERIFIED THAT WASH SOLUTION IS MADE CORRECTLY BY INSTRUMENT BY VERIFYING K LEVEL OF SOLUTION WAS WITHIN RANGE. RAN MA CARRYOVER BY ALTERNATING SERUM SAMPLES WITH URINE MA SAMPLES. STILL GETTING CARRYOVER ON FIRST REP OF MA FOLLOWING A SERUM TEST IS ELEVATED BY 15 UNITS. REPLACED SAMPLE PROBE ASSEMBLY AND RERAN SERUM/URINE MA CARRYOVER. ALL MA RESULTS WERE WITHIN EXPECTED PRECISION AND NO CARRYOVER DETECTED. MA ELEVATED RESULTS ARE DUE TO SAMPLE PROBE CARRYOVER. THREE SAMPLE PROBES BEING SENT TO CUSTOMER FOR FUTURE TROUBLE SHOOTING AND REPLACEMENT IF NEEDED. FSE RECOMMENDED FLUSHING CC SAMPLE PROBE USING BCI PROCEDURE IF CARRYOVER IS SUSPECTED AS ANOTHER ALTERNATIVE TO REPLACEMENT. THE SAMPLE PROBE REPLACEMENT APPEARS TO HAVE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH MICRO ALBUMIN (MA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. NO AFFECT TO PATIENTS, THE INCORRECT RESULTS HAVE NOT BEEN REPORTED OUT OF THE LABORATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1