BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 4597989 · Received March 13, 2015

    Report

    Report Number
    1823260-2015-02018
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. AS CALIBRATION AND QC DATA WAS ACCEPTABLE, A GENERAL ISSUE WITH THE REAGENT OR INSTRUMENT COULD BE EXCLUDED.

    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 RESULT FOR MULTIPLE ASSAYS FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RECEIVED AS A PRESPUN PARENT SAMPLE AND THE MODULAR PREANALYTIC ANALYZER (MPA) MADE TWO ALIQUOTS WHICH WERE SENT TO THE RESPECTIVE INSTRUMENTS. OF THE DATA PROVIDED, ONLY THE CREATININE RESULT WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 13.9 MG/DL. THE DOCTOR DID NOT BELIEVE THE RESULT AND SENT THE PATIENT TO BE REDRAWN THE NEXT DAY. THE RESULT FROM THE REDRAW SAMPLE WAS 1.2 MG/DL. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 1.0 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE INTERVIEWED THE CUSTOMER REGARDING THE ISSUE AND NOTED THE INSTRUMENT WAS IN USE AND UNAVAILABLE FOR SERVICE. THE CUSTOMER STATED THAT THEY HAVE NOT HAD ANY DISCREPANT RESULTS SINCE THE EVENT OVER 10 DAYS AGO AND THEY DO NOT BELIEVE ANYTHING IS WRONG WITH THE ANALYZER HARDWARE WISE. THE CUSTOMER DID NOT REQUIRE SERVICE. THE CUSTOMER'S QC AND RESULTS HAVE BEEN GOOD FOR THE LAST 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175328 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR