BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 3182632 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03765
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS -DEVICE SUBASSEMBLY-VACUUM TUBING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE DUE TO THE LACK OF RELEVANT INFORMATION. THE CUSTOMER COULD NOT PROVIDE RESULTS FOR CHLORIDE AND POTASSIUM FOR THE SAMPLES. IT WAS NOTED THAT THE RESULTS MEASURED ON THE C501 ANALYZER CANNOT SIMPLY BE COMPARED TO THE RESULTS FROM I-STAT. THE C501 MEASURES ISES INDIRECTLY, WHILE THE I-STAT MEASURES ISE DIRECTLY. IT WAS ALSO NOTED THAT THE CHANGE IN THE VACUUM TUBING WOULD BE REASONABLE IF OTHER TESTS WERE LOW.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA) ON FIVE PATIENTS. OF THOSE FIVE, IT WAS DETERMINED THAT ONE PATIENT HAD ERRONEOUS NA RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN MMOL/L. THE PATIENT'S INITIAL NA RESULT WAS 125, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ISTAT ANALYZER AND GENERATED A REPEAT NA RESULT OF 131. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT AND ISSUED A CORRECTED REPORT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER OF THE NA ELECTRODE IN USE WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE FOUND A HOLE IN THE RINSE NOZZLE VACUUM TUBING. HE REPLACED THE TUBING. THE CUSTOMER PERFORMED CALIBRATION AND QC AND ALL RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282768 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1