BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600

    MDR report key: 2071760 · Received April 28, 2011

    Report

    Report Number
    2122870-2011-01174
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN 13 X 100 MM SERUM TUBES AND CENTRIFUGED FOR 5 MINUTES AT 4000 RPM. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS AND CKMB HAD BEEN CALIBRATED ON THE MORNING OF THE EVENT. THE MEAN S0 RLUS ASSIGNED TO THE ACTIVE CKMB CALIBRATION CURVE AT THE TIME OF THE EVENT WERE 92,494 RLUS. THE PREVIOUS CALIBRATION CURVE MEAN S0 RLUS WERE AT 11,818 RLUS. PER BCI HOTLINE INSTRUCTIONS, THE CUSTOMER RECALIBRATED THE INSTRUMENT. AFTER RECALIBRATING THE CKMB ASSAY, THE MEAN S0 CALIBRATION CURVE RLUS WERE AT 11,565. PATIENT SAMPLES WERE REPEATED ON THE INSTRUMENT USING THE NEW CALIBRATION CURVE, AND RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING THESE CKMB RESULTS GENERATED BY THE UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER: "NO VALUE" RESULTS FLAGGED AS "IND" (INDETERMINATE) FOR TWO (2) PATIENTS, AND NEGATIVE RESULTS FLAGGED AS "ORL" (OUTSIDE REFERENCE LIMITS) FOR ONE (1)PATIENT. REPEAT TESTING OF THE SAMPLES RE-PRODUCED THESE RESULTS ON THE SAME INSTRUMENT WHILE REPEAT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL SAMPLES. 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 600 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600

    Patients

    Seq Age Sex Outcome Treatment
    1