BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2190005 · Received August 3, 2011

    Report

    Report Number
    2050012-2011-03822
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFM
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR CONTRIBUTED OR CAUSED THIS EVENT. NO SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2050012-2011-03822 AND 2050012-2011-03823.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY HIGH TOTAL BILIRUBIN (TBIL) RESULTS WERE GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT'S SAMPLES OVER TWO DAYS. THIS REPORT IS ONE OF TWO AND REPRESENTS THE ERRONEOUSLY HIGH TOTAL BILIRUBIN (TBIL) RESULT GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ON (B)(6) 2011 FOR ONE PATIENT SAMPLE. THE INITIAL TBIL RESULT WAS A SUPPRESSED VALUE WITH AN "OUT OF INSTRUMENT RANGE HIGH" INSTRUMENT FLAG. UPON REPEAT TESTING OF A DILUTION OF THE SAMPLE, THE LABORATORY TECHNICIAN INCORRECTLY CALCULATED THE END RESULT. THE TECHNICIAN DID NOT FOLLOW THE CALCULATION INSTRUCTIONS PROVIDED IN A BECKMAN COULTER INC. TECHNICAL APPLICATIONS LETTER DATED (B)(6) 2007. DUE TO THIS ERROR, THE REPORTED RESULT WAS TEN TIMES THE CORRECT RESULT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT IS UNKNOWN AS TO WHETHER HOSPITAL ADMISSION WAS BASED UPON THIS INCORRECT RESULT, HOWEVER FOR THE PURPOSES OF THIS REPORT IT IS ASSUMED THAT HOSPITAL ADMISSION WAS LINKED TO THE ERRONEOUS TBIL RESULT. A PHYSICIAN QUESTIONED THE HIGH RESULT AND THE SAMPLE WAS RETESTED ON A DILUTED SAMPLE UTILIZING THE CORRECT CALCULATION TO GENERATE THE FINAL RESULT. THIS RESULT WAS LOWER, MORE BELIEVABLE, AND REGARDED AS VALID. SPECIFIC PATIENT INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. INSTRUMENT TBIL QUALITY CONTROLS RESULTS DURING THE TIMEFRAME OF THE EVENT WERE FOUND TO BE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R