BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1728196 · Received June 18, 2010

    Report

    Report Number
    1823260-2010-03639
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 9, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    DUE TO MISSING DATA CONCERNING THE PATIENT AND THE ASSAY REACTION, AN INVESTIGATION WAS NOT POSSIBLE. A ROOT CAUSE COULD NOT BE IDENTIFIED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED AN ERRONEOUS CREATININE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FROM THE PRE-ADMISSION SAMPLE WAS 260 UMOL/L. THE DOCTOR CALLED THE LAB TO HAVE THE SAMPLE REPEATED AND THE RESULT WAS 61 UMOL/L. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE LOT NUMBER OF THE CREATININE REAGENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1