BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2760765 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04834
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, IT COULD NOT BE CONFIRMED THAT THE SV27 WAS THE CAUSE OF THIS EVENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE FIRST PATIENT SAMPLE WAS REPEATED ON A DIFFERENT COBAS 6000 ANALYZER, SERIAL NUMBER (B)(4). THE CUSTOMER PROVIDED DATA FOR AN ADDITIONAL PATIENT SAMPLE THAT HAD AN ERRONEOUS RESULT. PATIENT SAMPLE 2 IS FROM A (B)(6). AN ALIQUOT OF PATIENT SAMPLE 2 WAS ORIGINALLY RUN ON (B)(6) 2012 AND RESULTED AS 102 MMOL/L FOR SODIUM AND 127 MMOL/L FOR CHLORIDE. THESE ORIGINAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE DOCTOR. THE ORIGINAL SAMPLE TUBE WAS THEN USED TO REPEAT TESTING ON A DIFFERENT COBAS 6000 ANALYZER (SERIAL NUMBER (B)(4)) WHERE IT RESULTED AS 136 MMOL/L FOR SODIUM AND 99 MMOL/L FOR CHLORIDE. THE REPEAT VALUES WERE BELIEVED TO BE CORRECT AND REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 WAS NOT ADVERSELY AFFECTED BY THE EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE ISE SODIUM ELECTRODE LOT NUMBER WAS Q70 WITH AN EXPIRATION DATE OF 05/31/2013. THE ISE CHLORIDE ELECTRODE LOT NUMBER WAS C27 WITH AN EXPIRATION DATE OF 05/31/2013. THE FIELD SERVICE REPRESENTATIVE STATED THAT THE SV27 VALVE WAS NOT CLOSING ALL THE WAY OR FAST ENOUGH. IT WAS ALLOWING A DRIP TO FORM ON THE END OF THE SIPPER NOZZLE, WHICH MAY HAVE CAUSED SOME CARRY OVER THAT LEAD TO THE ERRONEOUS RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ION SELECTIVE ELECTRODE (ISE) SODIUM AND CHLORIDE. AN ALIQUOT OF THE SAMPLE INITIALLY RESULTED AS 120 MMOL/L FOR SODIUM AND 116 MMOL/L FOR CHLORIDE. THESE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY A DOCTOR. THE ORIGINAL DRAW TUBE WAS THEN USED TO REPEAT TESTING ON THE SAMPLE AND RESULTS WERE 132 MMOL/L FOR SODIUM AND 99 MMOL/L FOR CHLORIDE. THE REPEAT VALUES OF 132 MMOL/L FOR SODIUM AND 99 MMOL/L FOR CHLORIDE WERE BELIEVED TO BE CORRECT AND REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBERS OR EXPIRATION DATES FOR THE ISE SODIUM AND CHLORIDE ELECTRODES. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A MECHANICAL FAILURE OF ISE VALVE SV27. HE REPLACED THE VALVE. HE PERFORMED ISE CHECKS AND PRECISION SUCCESSFULLY. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROLS SUCCESSFULLY. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR