BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3052328 · Received April 11, 2013

    Report

    Report Number
    1823260-2013-02205
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON THE PATIENT IN QUESTION. THE INITIAL ION SELECTIVE ELECTRODE (ISE) CHLORIDE (CL) RESULT WAS 87.5 MMOL/L. THE SAMPLE WAS REPEATED ON COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4) AND GENERATED A REPEAT RESULT OF 105.4 MMOL/L. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CASE. IT WAS NOTED THAT A SAMPLE HANDLING ISSUE COULD CAUSE ERRONEOUS RESULTS, SINCE SUBSEQUENT MEASUREMENTS YEILDED PLAUSIBLE RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA) AND ISE POTASSIUM (K) ON ONE PATIENT SAMPLE. IT WAS DETERMINED THE NA RESULT WAS ERRONEOUS. ALL RESULTS ARE IN MMOL/L. THE INITIAL NA RESULT WAS 117. THE SAMPLE WAS REPEATED ON COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4) AND GENERATED A RESULT OF 135. THE INITIAL RESULT HAD BEEN VERBALLY GIVEN TO THE NURSE. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT, AND THE NURSE WAS CALLED BACK WITH THE CORRECTED RESULT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER FOR THE NA ELECTRODE IN USE WAS NOT PROVIDED. THE CUSTOMER REFUSED A FIELD SERVICE DISPATCH FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154693 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR