BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3162602 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03496
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 21, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS COULD NOT DETERMINE A SPECIFIC ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ION SELECTIVE ELECTRODE (ISE) SODIUM AND CHLORIDE. THE SAMPLE INITIALLY RESULTED AS 150 MMOL/L FOR ISE SODIUM AND 93 MMOL/L FOR ISE CHLORIDE. THESE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ABOUT SIX HOURS LATER SINCE A SECOND SAMPLE FROM THIS PATIENT GAVE A DELTA CHECK. THE REPEAT RESULTS WERE 138 MMOL/L FOR ISE SODIUM AND 104 MMOL/L FOR ISE CHLORIDE. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER NOTED ON (B)(6) 2013 THAT THERE WAS FIBRIN IN THE SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE LOT NUMBERS AND EXPIRATION DATES OF THE ISE SODIUM AND CHLORIDE ELECTRODES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. THE SYSTEM WAS CHECKED FOR DISCREPANCIES. HE RAN PRECISION TESTING AND THIS PASSED. THE CUSTOMER RAN QUALITY CONTROLS AND THESE WERE SUCCESSFUL. THE FIELD APPLICATION SPECIALIST ALSO PERFORMED A PRECISION STUDY AND THIS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263371 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR