BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 6858230 · Received September 12, 2017

    Report

    Report Number
    1823260-2017-01958
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 12, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE FIELD SERVICE ENGINEER PERFORMED SERVICE ACTIONS THAT ARE SEEN AS GENERAL MAINTENANCE MEASURES. THE INSTRUMENT WORKS ACCORDING TO SPECIFICATIONS AFTER THE FIELD SERVICE ENGINEER VISIT. THE INVESTIGATION FOUND THE POSSIBLE ROOT CAUSES COULD BE AIR IN THE SAMPLE CHANNEL, LEAKAGE CURRENT COMING FROM THE WASTE, OR AN OLD OR EXPIRED REFERENCE ELECTRODE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD RECEIVED DISCREPANT ISE INDIRECT NA, K, CL FOR GEN.2 FOR TWO PATIENT SAMPLES ON THE COBAS 6000 C (501) MODULE. FOR PATIENT 1 THE INITIAL NA RESULT WAS 126 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE INITIAL K RESULT WAS 3.80 AND THE REPEAT RESULT WAS 4.65 MMOL/L. THE INITIAL CL RESULT WAS 113.3 MMOL/L AND THE REPEAT RESULT WAS 99.1 MMOL/L. ON (B)(6) 2017 PATIENT 2 MALE, (B)(6) THE INITIAL NA RESULT WAS 107 MMOL/L AND THE REPEAT RESULT WAS 142 MMOL/L. THE INITIAL CL RESULT WAS 146 MMOL/L AND THE REPEAT RESULT WAS 101.9 MMOL/L. THE REPEAT TESTING WAS PERFORMED ON THE SAME C501 MODULE. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THERE WERE NO ADVERSE EVENTS. THE NA, CL, K ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THE ERRONEOUS RESULTS MAY HAVE BEEN CAUSED BY A COMPROMISED SAMPLE. ALTHOUGH EVERYTHING APPEARED FUNCTIONAL THE FIELD SERVICE ENGINEER CLEANED OUT THE FLOW PATH WITH ISE CLEANER AND HOT DISTILLED WATER. HE REPLACED THE TUBING AND ELECTRODES. HE CONDITIONED THE ELECTRODES. THE CALIBRATION, QUALITY CONTROL AND PRECISION TESTS WERE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639762 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR