BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1971480 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00439
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT CONCLUDED A SMALL AIR BUBBLE IN THE MEASURING CHANNEL MIGHT HAVE CAUSED THE EVENT. THE ROOT CAUSE FOR THE AIR BUBBLE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED FOR INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED DISCREPANT ION SPECIFIC ELECTRODE (ISE) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL SODIUM RESULT WAS >180 MMOL/L AND THE INITIAL POTASSIUM RESULT WAS 6.0 MMOL/L . THE SAMPLE WAS REPEATED ON THE SAME COBAS 6000 C501 ANALYZER AND GENERATED A SODIUM RESULT OF 141 MMOL/L AND POTASSIUM RESULT OF 4.53 MMOL/L. THE INITIAL SODIUM AND POTASSIUM RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THE DISCREPANCIES. THE SODIUM AND POTASSIUM ELECTRODE LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE. THE CUSTOMER RAN QUALITY CONTROL AND REPORTED NO FURTHER ISSUES AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1