BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3111666 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02929
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 4, 2013
    Report Date
    June 18, 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

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

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. THE INSTRUMENT WAS WORKING TO SPECIFICATION SINCE THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULT FOR ONE PATIENT ON THEIR C501 ANALYZER. THE PATIENT'S SAMPLE WAS CENTRIFUGED AND ALIQUOTED BY THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE PRIOR TO THE INITIAL AND REPEAT TESTS. THE PATIENT'S INITIAL SODIUM RESULT WAS 160 MMOL/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT HAD ANOTHER SAMPLE DRAWN LATER IN THE DAY AND THE RESULT WAS 134 MMOL/L. THE PHYSICIAN THEN QUESTIONED THE INITIAL RESULT. THE REPEAT RESULT FROM THE ORIGINAL SAMPLE WAS 133 MMOL/L. THE REPEAT RESULT WAS CONSIDERED CORRECT AND ISSUED AS A CORRECTED REPORT. THE PATIENT WAS NOT TREATED OR HARMED BY THE ERRONEOUS RESULT. THERE WERE NO ADVERSE EVENTS. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SIPPER NOZZLE WAS WORN AND THERE WAS A FLUIDICS FAILURE. HE REPLACED THE SIPPER NOZZLE ALONG WITH THE SIPPER AND PINCH TUBING. HE PERFORMED SUCCESSFUL ISE CHECKS. HE PERFORMED A PRECISION CHECK WITH RESULTS WITHIN SPECIFICATIONS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211771 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1