BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON CX4 DELTA

    MDR report key: 788250 · Received November 21, 2006

    Report

    Report Number
    2050012-2006-00030
    Event Type
    Other
    Date Received
    November 21, 2006
    Date of Event
    October 29, 2006
    Report Date
    November 21, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE WAS IN THE CUSTOMER'S LAB ON 11/6/06 AND 11/7/06 AND PERFORMED MULTIPLE HARDWARE REPAIRS TO THE INSTRUMENT (DETAILS NOT PROVIDED). SAMPLES A AND B WERE SENT TO BECKMAN COULTER INC (BCI) FOR INVESTIGATION. BASED ON IN HOUSE TESTING, SAMPLE A AND B CONSISTENTLY RECOVERED "RESULTS SUPPRESED, OIR HIGH" (OUT OF INSTRUMENT RANGE HIGH). THE CUSTOMER CONFIRMED THAT VANC RESULT OF "OIR HIGH" IS CORRECT. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY LOW VANCOMYCIN (VANC) RESULTS THAT WERE GENERATED BY THE SYNCHRON CX4 DELTA INSTRUMENT. A PATIENT'S NEAT SAMPLE (A) WAS TESTED FOR VANC AND A RESULT OF 47.6 UG/ML WAS OBTAINED. A FRESH SAMPLE (B) WAS COLLECTED FROM THE PATIENT ON THE NEXT DAY AND TESTED NEAT FOR VANC; THE RESULT WAS 47.0 UG/ML. ON THE FOLLOWING DAY, BOTH SAMPLES WERE RETESTED NEAT FOR VANC AND RESULTS OF "SUPPRESSED, OIR HIGH" WERE OBTAINED FOR BOTH SAMPLES. SAMPLES A AND B WERE DILUTED AND THEN RAN FOR VANC. THE DILUTED VANC RESULTS WERE: 113.5UG/ML FROM SAMPLE A AND 98.8UG/ML FROM SAMPLE B. THE CUSTOMER AMENDED THE VANC RESULT. IN ADDITION, BOTH SAMPLES WERE SENT TO A REFERENCE LAB AND TESTED ON A ROCHE FPIA INSTRUMENT FOR VANC. THE VANC RESULTS OBTAINED FROM THE ROCHE FPIA INSTRUMENT WERE: 123.8UG/ML AND 95.6UG/ML FOR SAMPLE A AND B RESPECTIVELY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. BOTH, THE ORIGINAL AND THE AMENDED RESULTS WERE ABOVE THE TOXIC RANGE. PATIENT MEDICATION WAS CORRECTLY WITHHELD BASED UPON THE INITIALLY OBTAINED VANC RESULT OF 47.0UG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX4 DELTA CLINICAL CHEMISTRY ANALZYER JJC BECKMAN COULTER, INC. CX4 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA