BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEMS

    MDR report key: 2140238 · Received June 26, 2011

    Report

    Report Number
    2050012-2011-02672
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION NOT PROVIDED QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC AFTER THE EVENT WAS LOW. A BCI FIELD SERVICE ENGINEER (FSE) FOUND AND CLEANED A WHITE FILM FROM THE NA REFERENCE ELECTRODE. FSE PERFORMED A PM ON THE INSTRUMENT AND VERIFIED PERFORMANCE CHANGE FROM: A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW SODIUM AND CHLORIDE PATIENT RESULTS GENERATED ON THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. INFORMATION NOT AVAILABLE IF THE SAMPLES WERE REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLES WERE REPEATED. TO: A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW SODIUM (NA) AND CHLORIDE (CL) PATIENT RESULTS GENERATED ON THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE SAMPLES FAILED DELTA CHECKS, THE UNIT WAS TROUBLESHOT AND THE SAMPLE REPEATED AMENDED. THE SAMPLES WERE SENT TO ANOTHER LABORATORY FOR VERIFICATIONS. THE CUSTOMER PROVIDED DATA FROM 6 PATIENTS. OF THE 6 SAMPLES, THE DIFFERENCE IN NA RECOVERIES FOR 2 OF THE PATIENTS WAS WITHIN ASSAY PRECISION CLAIMS; THE RESULTS ARE NOT INCLUDED. PATIENT RESULTS ARE PROVIDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE LOW RESULTS REPORTED CHANGE TO: ORIGINAL NA RESULT: 133, 138, 135, 130, REPEATED NA RESULT (DIFFERENT LAB): 138, 142, 141, 138. (B)(6). (B)(4). CHANGE FROM: NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE ISSUE HAS BEEN ESCALATED TO A SPECIALIST. TO: SAMPLE INFORMATION NOT PROVIDED QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC AFTER THE EVENT WAS LOW. A BCI FIELD SERVICE ENGINEER (FSE) FOUND AND CLEANED A WHITE FILM FROM THE NA REFERENCE ELECTRODE. FSE PERFORMED A PM ON THE INSTRUMENT AND VERIFIED PERFORMANCE

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE ISSUE HAS BEEN ESCALATED TO A SPECIALIST.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW SODIUM AND CHLORIDE PATIENT RESULTS GENERATED ON THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. INFORMATION NOT AVAILABLE IF THE SAMPLES WERE REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLES WERE REPEATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOW SODIUM (NA) AND CHLORIDE (CL) PATIENT RESULTS GENERATED ON THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE SAMPLES FAILED DELTA CHECKS, THE UNIT WAS TROUBLESHOT AND THE SAMPLE REPEATED AMENDED. THE SAMPLES WERE SENT TO ANOTHER LABORATORY FOR VERIFICATIONS. THE CUSTOMER PROVIDED DATA FROM 6 PATIENTS. OF THE 6 SAMPLES, THE DIFFERENCE IN NA RECOVERIES FOR 2 OF THE PATIENTS WAS WITHIN ASSAY PRECISION CLAIMS; THE RESULTS ARE NOT INCLUDED. PATIENT RESULTS ARE PROVIDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE LOW RESULTS REPORTED

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization