BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2433809 · Received January 31, 2012

    Report

    Report Number
    2050012-2012-00245
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT EVALUATION WAS PERFORMED BY BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICE ASSISTED CUSTOMER TROUBLESHOOTING. THE CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER IN THE REPLACEMENT OF THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE, AND PERFORMED THE NECESSARY ALIGNMENTS. THIS REPAIR RESOLVED THE ISSUE. UPON COMPLETION OF THE NECESSARY REPAIRS THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. THE FAILURE MODE APPEARS TO BE THE CC SAMPLE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2012 ERRONEOUS LOW ALKALINE PHOSPHATASE (ALP), ASPARTATE AMINOTRANSFERASE (AST), ALANINE TRANSAMINASE (ALT) AND TOTAL BILIRUBIN (TBIL) RESULTS, AND SUPPRESSED TRIGLYCERIDE (TG) RESULTS WITH INSTRUMENT FLAGS WERE GENERATED FROM AN UNICEL DXC 800 SYNCHRON SYSTEM FOR APPROXIMATELY ONE HUNDRED PATIENT SAMPLES. THE INSTRUMENT FLAG ASSOCIATED WITH THE SUPPRESSED RESULTS WAS A "OUT OF INSTRUMENT RANGE LOW" MESSAGE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT SEVENTEEN PATIENTS POSSESSED ERRONEOUSLY LOW AND/OR SUPPRESSED TBIL, TG, ALP, AST, ALT, GENTAMICIN(GEN), CHOLESTEROL (CHOL), (HDLD) DIRECT HIGH-DENSITY LIPOPROTEIN CHOLESTEROL, (URIC) URIC ACID, MAGNESIUM (MG), (FE) IRON, VALPROIC ACID (VPA), AND/OR TRANSFERRIN (TRFN) RESULTS. NOTE THAT SUPPRESSED RESULTS FOR THESE ANALYTES WERE NOT REGARDED AS ERRONEOUS BUT HAVE BEEN INCLUDED AS PART OF THIS REPORT FOR FULL DESCRIPTION OF THE INCIDENT. THE CUSTOMER WAS NOT QUESTIONING ANY OTHER CHEMISTRY RESULTS PROVIDED FOR THESE PATIENTS AS PART OF THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT TESTING ON ANOTHER INSTRUMENT, ALL NUMERICAL RESULTS RECOVERED HIGHER. THOSE PATIENT RESULTS WHICH WERE INITIALLY SUPPRESSED RECOVERED WITH A NUMERICAL VALUE. ONE PATIENT RESULT RECOVERED WITH A "NO REAGENT ON SYSTEM" MESSAGE. NO ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF THE INSTRUMENT PERFORMANCE DATA PROVIDED BY THE CUSTOMER INDICATED THAT ALP, ALT, AST AND TBIL QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS AFTER THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1