BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1984347 · Received February 10, 2011

    Report

    Report Number
    2122870-2011-00378
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CKMB SAMPLE WAS COLLECTED IN A BD LIHEP PLASMA TUBE AND CENTRIFUGED FOR FOUR (4) MINUTES AT 3000 RPM. PER THE CUSTOMER SUPPLIED QC CHARTS, LEVELS 2 AND 3 CKMB QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. LEVEL 1 CKMB QC WAS OUT OF RANGE LOW PRIOR TO AND ON THE DAY OF THE EVENT. IT IS UNKNOWN IF THE CUSTOMER REPEATED QC TO OBTAIN A PASSING RESULT. PER THE CUSTOMER, A ROUTINE SYSTEM CHECK WAS LAST PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND A TEN (10) REPLICATE PRECISION TEST ON EACH OF THE FOUR REAGENT PIPETTORS WHICH ALL PASSED WITHIN INSTRUMENT AND ASSAY SPECIFICATIONS. THE FSE ALSO PULLED THE PATIENT SPECIMENS FOR REVIEW AND NOTED SOME MINOR DEBRIS AND RED CELLS ON THEM. THE FSE RAN THREE (3) REPLICATES OF EACH OF THE PATIENT'S SAMPLES AND ALL RESULTS WERE REPRODUCIBLE. THE FSE DID NOT NOTE ANY HARDWARE ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A HIGHER THAN EXPECTED CREATININE KINASE - MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1