BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX

    MDR report key: 1334270 · Received March 5, 2009

    Report

    Report Number
    2050012-2009-00029
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 20, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC DID NOT INDICATE A PROBLEM AND SUBSEQUENT SAMPLES GAVE NORMAL RESULTS. SERVICE WAS INITIATED AND PARTS WILL BE RETURNED FOR INVESTIGATION IF APPLICABLE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH CREATININE (CRE) RESULTS GENERATED BY THE SYNCHRON CX9 ALX INSTRUMENT. TWO EXAMPLES OF THE ERRONEOUS RESULTS WERE PROVIDED: THE FIRST PATIENT SAMPLE GAVE A SUPPRESSED OIR (OUT-OF-INSTRUMENT RANGE) LOW RESULT AND WHEN RERUN AFTER RECALIBRATION, GAVE A RESULT OF 1.1MG/DL. A SAMPLE OBTAINED FROM ANOTHER PATIENT GAVE A RESULT OF 1.9MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AND UPON RERUN IT GAVE A RESULT OF 0.6MG/DL. TREATMENT WAS NOT INITIATED OR WITHELD FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1