BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2508239 · Received March 28, 2012

    Report

    Report Number
    2050012-2012-00774
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFM
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS IT WAS BELIEVED TO BE SAMPLE RELATED. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/CHEMISTRY PERFORMANCE DATA INDICATED THAT TBIL CALIBRATION AND QUALITY CONTROL RESULTS HAD BEEN ACCEPTABLE. NO CUSTOMER MAINTENANCE WAS NEEDED, AND NO MAINTENANCE WAS PERFORMED SPECIFICALLY FOR THIS ISSUE. BECKMAN COULTER INC. CUSTOMER INFORMATION SHEETS INDICATE RED BLOOD CELL HEMOLYSATE AS A SOURCE OF INTERFERENCE; HOWEVER THE SPECIFIC PATIENT SAMPLE INVOLVED IN THIS EVENT WAS NOT INTERFERENCE TESTED AND HENCE THIS CANNOT BE CONFIRMED FOR THIS EVENT. THE BECKMAN COULTER INC. REPRESENTATIVE ADVISED THE CUSTOMER TO REJECT ALL HEMOLYZED NEONATAL HEEL STICK SAMPLES FOR TBIL. WHILE THE CAUSE MAY HAVE BEEN SAMPLE-SPECIFIC INTERFERENCE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2050012-2012-00774, 2050012-2012-00775.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED TOTAL BILIRUBIN (TBIL) RESULTS WERE GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM FOR ONE PATIENT'S SAMPLE. THIS REPORT REPRESENTS THE ERRONEOUSLY ELEVATED TBIL RESULTS GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2012. THE INITIAL PATIENT SAMPLE WAS A HEMOLYZED HEEL-STICK SAMPLE RUN IN A SAMPLE CUP. THE ERRONEOUS, INITIAL TBIL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TRANSPORTED AND ADMITTED TO A HOSPITAL FOR FOLLOW-UP TREATMENT BASED UPON THE TBIL RESULTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT THE PATIENT WAS REDRAWN AT THE HOSPITAL VIA VENIPUNCTURE AND RETESTED ON AN ALTERNATE INSTRUMENT. THE RESULTS WERE LOWER AND REGARDED AS VALID. THE PATIENT'S HISTORY AND CURRENT LABORATORY RESULTS DID NOT NOTE ANY PATIENT ABNORMALITIES, AND THE REDRAWN SAMPLE'S RESULTS WERE BELOW THE THRESHOLD FOR PHOTOTHERAPY. THE PATIENT WAS NOT TREATED AND WAS DISCHARGED. NO OTHER PATIENT SAMPLES WERE AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Hospitalization SYNCHRON TOTAL BILIRUBIN REAGENT