BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1912246 · Received December 2, 2010

    Report

    Report Number
    1823260-2010-07092
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 16, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIIFED. NO INSTRUMENT MALFUNCTION WAS DETECTED BASED ON THE INFORMATION PROVIDED. INSUFFICIENT INFORMATINO WAS PROVIDED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE USER DISCOVERED QUESTIONABLE ISE RESULTS FOR ONE PATIENT SAMPLE DUE TO A NEGATIVE ANION GAP. THE USER PULLED THE SAMPLE AND REPEATED TESTING. OF THE DATA PROVIDED, THE RESULTS FOR SODIUM AND POTASSIUM WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. THE INITIAL SODIUM RESULT WAS 110 AND THE REPEAT RESULT WAS 122. THE REPEAT RESULT FROM ANOTHER COBAS C501 WAS 122. THE INITIAL POTASSIUM RESULT WAS 4.91 AND THE REPEAT RESULT WAS 6.11. THE REPEAT RESULT FROM ANOTHER COBAS C501 WAS 6.03. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SODIUM AND POTASSIUM ELECTRODE LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND TOOK NO REMEDIAL ACTION. TO VERIFY THE ANALYZER OPERATION, HE RAN ISE PERFORMANCE CHECKS WHICH PASSED.

    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
    1 036 YR