BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3022640 · Received March 27, 2013

    Report

    Report Number
    1823260-2013-01859
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    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 LOW ION SELECTIVE ELECTRODE (ISE) SODIUM RESULT FOR 39 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR 28 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER CALLED THE CORRECTED REPORTS AND STATED THE NO ONE WAS TREATED OR ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVES DETERMINED THERE WAS A FAILURE OF THE RINSE NOZZLE ON THE RINSE MECHANISM AND THE RINSE MECHANISM WAS NOT CLEANING THE CELLS. THEY REMOVED A CLOG FROM THE RINSE NOZZLE AND REPLACED THE VACUUM DIAPHRAGMS. THEY CONFIRMED THE INSTRUMENT WAS OPERATING TO SPECIFICATION WITH SUCCESSFUL CALIBRATION AND QC RUN AND A PRECISION CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125399 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1