BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2063422 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02107
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 3, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLY LOW RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM AND CHLORIDE FOR 18 PATIENT SAMPLES. BASED UPON THE INFORMATION PROVIDED, THE CUSTOMER HAD 4 DISCREPANT SODIUM RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY ON THEIR COBAS (B)(4)..... ADDITIONAL INFORMATION: A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE SODIUM ELECTRODE IS NOT AVAILABLE FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLY LOW RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM AND CHLORIDE. THEY HAD FIVE DISCREPANT SODIUM RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY ON THEIR COBAS C501. THE CUSTOMER STATED THEY HAD BEEN RECEIVING A NOISE ERROR MESSAGE ON THE ANALYZER SINCE (B)(6) 2011. THEY HAD BEEN RUNNING CONTROLS EVERY TWO TO FOUR HOURS AND RECALIBRATING AS NECESSARY. BEFORE THE EVENT, THEIR CONTROLS WERE WITHIN SPECIFICATION. WHEN THEY RAN THE CONTROLS NEXT, THE HIGH CONTROL WERE RUNNING LOW. THEY RECALIBRATED THE ANALYZER AND REPEATED ALL SAMPLES ANALYZED SINCE THE LAST PASSING CONTROLS. THEY REPEATED THE RESULTS ON THE SAME C501 AND SOME ON ANOTHER C501. ALL RESULTS REPORTED IN MMOL/L. THE FIRST PATIENT'S SODIUM RESULT WAS 132. THE REPEAT RESULT WAS 139. THE SECOND PATIENT'S SODIUM RESULT WAS 144. THE REPEAT RESULT WAS 150 ACCOMPANIED BY A DATA FLAG. THE THIRD PATIENT'S SODIUM RESULT WAS 140. THE REPEAT RESULT WAS 146 ACCOMPANIED BY A DATA FLAG. THE FOURTH PATIENT'S SODIUM RESULT WAS 131. THE REPEAT RESULT WAS 137. THERE WAS NO ALLEGATION OF ANY ADVERSE AFFECTS FROM THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE ISSUE WAS A DAMAGED ISE SODIUM ELECTRODE. HE REPLACED THE DAMAGED ELECTRODE. HE THEN RAN PERFORMANCE CHECKS WITH PASSING RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1