BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3050884 · Received April 10, 2013

    Report

    Report Number
    1823260-2013-02197
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A SYSTEMATIC ISSUE CAN BE EXCLUDED, SINCE ONLY ONE SAMPLE WAS AFFECTED AND CALIBRATION AND QC RESULTS WERE WITHIN SPECIFICATION. AN INSTRUMENT MALFUNCTION COULD NOT BE DETECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), ISE POTASSIUM (K), AND ISE CHLORIDE (CL) FOR ONE PATIENT SAMPLE. IT WAS DETERMINED THAT THE NA AND K RESULTS WERE ERRONEOUS. ALL RESULTS ARE IN MMOL/L. THE PATIENT HAD AN INITIAL NA RESULT OF 82, ACCOMPANIED BY A DATA FLAG. THE INITIAL K RESULT WAS 2.6, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND GENERATED A REPEAT NA RESULT OF 139 AND A REPEAT K RESULT OF 4.6. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM BY THE PHYSICIAN BECAUSE OF THE ORIGINAL RESULTS. NO FURTHER PATIENT INFORMATION COULD BE PROVIDED BY THE CUSTOMER. IT IS UNKNOWN IF THERE WAS AN ADVERSE EVENT. THE LOT NUMBERS FOR THE NA AND K ELECTRODES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE FOR THE ISSUE. HE PERFORMED A PRECISION CHECK, WHICH WAS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153731 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR