BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2500648 · Received March 22, 2012

    Report

    Report Number
    2050012-2012-00778
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS THE ISSUE WAS RESOLVED VIA BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING. THE CUSTOMER INDICATED THAT AFTER FLUSHING THE CARTRIDGE CHEMISTRY PROBE THE INSTRUMENT WAS RUNNING WELL AND NO OTHER ISSUES WERE NOTED. THE ISSUE WAS RESOLVED BY FLUSHING THE CARTRIDGE CHEMISTRY PROBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ALB (ALBUMIN), TP (TOTAL PROTEIN), BUN (BLOOD UREA NITROGEN) AND CRE (CREATININE) RESULTS WITH "OUT OF INSTRUMENT RANGE (OIR) LOW" FLAGS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR TWO PATIENT SAMPLES. THE CUSTOMER ASSESSED THE INSTRUMENT FOR LOOSE PROBE CONNECTIONS AND LEAKS WITHOUT IDENTIFYING ANY ABNORMALITIES. BECKMAN COULTER INC. ADVISED THE CUSTOMER TO FLUSH THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AND THEN PRIME THE INSTRUMENT TEN TIMES. THE CUSTOMER INDICATED THAT POST REPAIR ASSESSMENT OF CALIBRATIONS, CARTRIDGE CHEMISTRY QUALITY CONTROL RESULTS AND NEWLY GENERATED PATIENT RESULTS WERE ALL NORMAL, WITH NO OIR LOW RESULTS. THE CUSTOMER THEN REVIEWED PATIENT RESULTS GENERATED PRIOR TO THE REPAIR AND INDICATED THAT SEVEN PATIENTS POSSESSED ERRONEOUSLY LOW CARTRIDGE CHEMISTRY RESULTS. THESE ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THE INVOLVEMENT OF SIX PATIENTS WITH INITIALLY LOW OR SUPPRESSED BLOOD UREA NITROGEN (BUN), DIRECT LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDLD), CREATININE (CR-S), GLUCOSE (GLU), TOTAL PROTEIN (TP), ALBUMIN (ALB), ALKALINE PHOSPHOTASE (ALP), ASPARTATE AMINOTRANSFERASE (AST), ALANINE TRANSAMINASE (ALT), HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH), URIC ACID (URIC),TOTAL BILIRUBIN (TBIL), TRIGLYCERIDE (TG), DIRECT HIGH-DENSITY LIPOPROTEIN CHOLESTEROL (HDLD) AND/OR CREATINE KINASE (CK) RESULTS. UPON REPEAT, AFTER THE CUSTOMER INITIATED INSTRUMENT REPAIRS, THESE PATIENTS' RESULTS WERE HIGHER AND CONSIDERED VALID.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1