BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2182711 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03090
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT ALANINE AMINOTRANSFERASE (ALT) RESULTS FOR ONE (1) PATIENT SAMPLE ON THEIR UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE ANALYZER HAD GENERATED AN ALT RESULT OF "RESULTS SUPPRESSED - ORDAC LO". THE CUSTOMER MISINTERPRETED THE "LIMITATIONS" SECTION OF THE ALT CHEMISTRY INFORMATION SHEET (CIS) WHICH STATES IF THE ANALYZER GENERATES AN "OIR LO" MESSAGE, THE SAMPLE SHOULD BE DILUTED 1:20 WITH SALINE. THE CUSTOMER ERRONEOUSLY FOLLOWED THIS INSTRUCTION, DILUTED THE SAMPLE 1:21, AND OBTAINED AN ALT RESULT OF 81 IU/L ON THE ANALYZER. THE CUSTOMER DID NOT REPORT THIS RESULT. BECAUSE THE RESULT OBTAINED WAS NOT AS HIGH AS THE CUSTOMER WAS EXPECTING, THE CUSTOMER PERFORMED A SEPARATE DILUTION OF THE SAMPLE 1:2 WITH SALINE AND RE-ASSAYED FOR ALT. THE ANALYZER GENERATED A RESULT OF 13 IU/L. THE CUSTOMER CONTACTED BEC FOR GUIDANCE IN WHICH RESULT TO REPORT (81 IU/L OR 13 IU/L). THE BEC SPECIALIST ADVISED THE CUSTOMER TO REPORT THE RESULT OF 13 IU/L. THE BEC SPECIALIST INFORMED THE CUSTOMER THAT THE LIMITATIONS SECTION OF THE CIS WAS NOT WRITTEN TO ADDRESS AN "ORDAC LO" MESSAGE WHICH THE CUSTOMER HAD OBTAINED. THE BEC SPECIALIST ALSO INFORMED THE CUSTOMER THAT QUESTIONABLE LOW RUNS SHOULD BE CHECKED BY DILUTION OF A SAMPLE OF KNOWN ALT CONCENTRATION WITH AN EQUAL VOLUME OF THE PATIENT SAMPLE (E.G., A 1:2 DILUTION). IF THE LOW PATIENT CONCENTRATION IS NOT CONFIRMED BY THE DILUTION OF THE KNOWN SAMPLE WITH THE PATIENT SAMPLE, THEN THE OPERATOR SHOULD CHECK FOR HIGH ALT CONCENTRATION IN THE PATIENT SAMPLE BY RUNNING SERIAL DILUTIONS OF THE SAMPLE WITH SALINE, BEGINNING WITH A 1:2 DILUTION, UNTIL TWO (2) OR MORE DILUTIONS GIVE NET ALT RESULTS THAT CALCULATE TO MATCHING CONCENTRATIONS. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE AS THERE WAS NO MALFUNCTION OF THE ANALYZER. THE ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ALT REAGENT