BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1901039 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06785
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE NH3L (AMMONIA) RESULTS FOR ONE PATIENT SAMPLE. THE ORIGINAL SAMPLE WAS POURED INTO A FALSE BOTTOM TUBE DUE TO A LOW SAMPLE VOLUME AND GENERATED A RESULT OF 151 UG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAME SAMPLE IN THE SAME FALSE BOTTOM TUBE WAS THEN TESTED ON COBAS C501 SERIAL NUMBER (B)(4) WITH A RESULT OF 18 UG/ML. THE SAME SAMPLE IN THE SAME FALSE BOTTOM TUBE WAS THEN PUT BACK ON THE ORIGINAL ANALYZER AND GENERATED A RESULT OF 27 UG/ML. THIS RESULT WAS SENT AS A CORRECTIVE REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE AMMONIA REAGENT LOT NUMBER WAS 61981001. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS UNKNOWN. HE PERFORMED PRECISION AND ACCURACY CHECKS AND STATED THE UNIT WAS OPERATIONAL WITH NO ERRORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1