BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2022319 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01457
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 27, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS NEITHER THE PATIENT SAMPLE NOR THE REACTION DATA WAS AVAILABLE. FURTHER ROOT CAUSE ANALYSIS WAS NOT POSSIBLE. THE SUSPECTED INTERFERENCE OF FUROSEMID WAS TESTED, BUT NO INTERFERENCE WAS FOUND UP TO THE 5 FOLD MAXIMUM DAILY DOSAGE. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW CREATININE PLUS VERSION 2 (CREATININE) RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT. ALL RESULTS ARE IN MG/DL. THE INITIAL RESULT WAS 0.62 AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS TESTED ON A DIMENSION ANALYZER. THE RESULT WAS 2.71. THE SAMPLE WAS ALSO TESTED ON AN ABL ANALYZER AND THE RESULT WAS 2.78. ON (B)(6) 2011, THE SAMPLE WAS TESTED ON COBAS C501 SERIAL NUMBER (B)(4) AND THE RESULT WAS 0.83. ON (B)(6) 2011, A NEW SAMPLE FROM THE PATIENT WAS TESTED AND THE RESULT WAS 0.49. THE SAMPLE WAS REPEATED ON THE ABL ANALYZER AND THE RESULT WAS 2.04. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 63485001. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE INSPECTED THE INSTRUMENT AND SAMPLE AND STATED ALL APPEARED NORMAL. HE SUSPECTED SOME TYPE OF INTERFERENCE IN THE SAMPLE AS THE ISSUE REPRODUCED. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED PRECISION TESTING ON CREATININE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR