BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIH

    MDR report key: 2040447 · Received April 5, 2011

    Report

    Report Number
    2050012-2011-00881
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL LTD
    Product Code
    JJY
    PMA / PMN Number
    CLASS1EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT SERUM INDICES (LIH - LIPAEMIA, ICTERUS, HAEMOLYSIS) WERE RUN ON (B)(6) 2010 ON A SAMPLE FROM A PATIENT WITH ACUTE LIVER FAILURE OF UNDEFINED AETIOLOGY. ON (B)(6) 2011, ALTHOUGH THE SAMPLE WAS ICTERIC AND HAD A TOTAL BILIRUBIN (TBIL) CONCENTRATION OF > 50 MG/DL, ALL THREE INDICES GAVE NORMAL RESULTS. A SECOND SAMPLE COLLECTED 12 HOURS LATER GAVE THE EXPECTED RESULTS WHERE ALL 3 INDICES SHOWED ABN INDICATING THAT THE SAMPLE HAD ABNORMAL OPTICAL CHARACTERISTICS AND REQUIRED VISUAL INSPECTION. LIVER TRANSPLANTATION WAS PERFORMED ON (B)(6) 2011 TBIL REMAINED ELEVATED FOR SEVERAL DAYS THEREAFTER AND THE SERUM INDICES CONTINUED TO SHOW MISLEADING RESULTS UP UNTIL (B)(6) 2011. FROM (B)(6) 2011, THE INDICES PERFORMED AS EXPECTED. PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIH SERUM INDICES (LIH, LIPAEMIA, ICTERUS, HAEMOLYSIS) JJY BECKMAN COULTER BIOMEDICAL LTD OSR62166 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1