BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1812772 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05020
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. IT WAS DETERMINED A POTENTIAL CAUSE WAS INCORRECT PRE-ANALYTICAL SAMPLE HANDLING WHICH LED TO CONTAMINATION ON THE INSTRUMENT. NO SIMILAR EVENTS HAVE BEEN REPORTED SINCE DECONTAMINATION OF THE INSTRUMENT. THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE VISITED THE SITE ON (B)(6) 2010 DUE TO CONTINUED ISSUES WITH SODIUM RECOVERY AND FOUND CONTAMINATION OF THE ISE FLOW PATH. HE PERFORMED ISE SYSTEM CLEANING. PERFORMANCE TESTS WERE RUN WHICH PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT LOST CONSCIOUSNESS AND EXPERIENCED A STROKE. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT COMMON CAROTID ARTERY. THIS 8.0-29 CAROTID WALLSTENT WAS IMPLANTED IN THE LESION SUCCESSFULLY WITHOUT COMPLICATIONS RESULTING IN LESS THAN 30% RESIDUAL STENOSIS. THE PATIENT WAS GIVEN ANTICOAGULANT/ANTIPLATELETS BEFORE AND DURING THE PROCEDURE. THE PATIENT WAS KEPT FOR OBSERVATION. FOR THE FIRST HOUR AFTER THE PROCEDURE, THE PATIENT WAS ABLE TO ANSWER QUESTIONS. AFTER A FEW HOURS, THE PATIENT SHOWED "EXTRAORDINARY SYMPTOMS" INCLUDING LOSS OF CONSCIOUSNESS. THE PHYSICIAN SENT THE PATIENT FOR AN ANGIOGRAM WHERE A BLOOD CLOT WAS OBSERVED IN THE RIGHT SIDE OF THE BRAIN. 12 HOURS POST PROCEDURE, A CEREBRAL HEMORRHAGE OCCURRED AND THE PATIENT WAS TAKEN TO SURGERY. THE SURGERY WAS SUCCESSFUL, HOWEVER, THE PATIENT REMAINS UNCONSCIOUS ON LIFE SUPPORT.

    Description of Event or Problem · 1

    THE USER RECEIVED ERRATIC RESULTS FOR SODIUM ON THE COBAS 6000 CORE ANALYZER. TWO PATIENT SAMPLES WERE INVOLVED IN THE EVENT. ONE PATIENT SAMPLE WAS DISCREPANT. THE INITIAL RESULT FOR SODIUM GAVE 128 MMOL/L. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE USER SAID THEY HAVE A POLICY TO REPEAT ANY LOW SODIUM RESULTS AND REPEATED THIS SAMPLE WHICH GAVE A SODIUM RESULT OF 137 MMOL/L. THE USER POURED THE SAMPLE INTO A CUP AND REPEATED THE SAMPLE TWICE GIVING SODIUM RESULTS OF 131 MMOL/L EACH TIME. THESE RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE USER REPEATED THE ORIGINAL SAMPLE TUBE FOR THIS SAMPLE ON ANOTHER COBAS 6000 ANALYZER (#2) (B)(4), AT THE SITE, WHICH GAVE A SODIUM RESULT OF 132 MMOL/L. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENT WAS NOT AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS E03. THE FIELD SERVICE REPRESENTATIVE (FSR) DETERMINED THE CAUSE WAS FLUIDICS FAILURE. HE PERFORMED CLEANING MAINTENANCE. THE FSR AND CUSTOMER RAN PERFORMANCE TESTING WHICH RESULTED WITHIN RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "OPENED THE FIRST STERILE PACKAGING AND NOTICED THAT THERE WAS A HOLE IN THE OUTER AND INNER STERILE PACKAGING (NOT THE OUTSIDE BOX ITSELF). DID NOT USE, AND USED ANOTHER IMPLANT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1