BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER

    MDR report key: 1875197 · Received October 19, 2010

    Report

    Report Number
    2050012-2010-01031
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K188495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. NO OTHER PATIENT RESULTS WERE QUESTIONED. THIS WAS BELIEVED TO BE A SAMPLE SPECIFIC EVENT. SERVICE WAS NOT APPLICABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A SUPPRESSED CREATINE KINASE (CK) RESULT GENERATED BY THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER FOR ONE PATIENT ON A NEAT SAMPLE, WHICH GAVE A "SUBSTRATE DEPLETION" FLAG. WHEN THE SAMPLE WAS DILUTED 1:11, A RESULT OF 2 IU/L WAS GENERATED. A 1:2 DILUTION GAVE A RESULT OF 1 IU/L. THE SAMPLE WAS SENT TO A REFERENCE LAB, WITH A FINAL REPORTED RESULT OF 15,000 IU/L. THE PREVIOUS CK RESULT FROM THIS PATIENT WAS 5000 IU/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1