BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1982215 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00707
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS OVER TIME AND PROVIDED AN EXAMPLE OF CREATINE KINASE (CK) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 61 U/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 78 U/L WITH A DATA FLAG. THE SAMPLE WAS RETESTED WITH A DILUTION AND THE RESULT WAS GREATER THAN 30% DIFFERENT FROM THE ORIGINAL AND FIRST REPEAT RESULT. THE USER COULD NOT PROVIDE THE SPECIFIC RESULT. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CK REAGENT LOT NUMBER WAS 63315601. THE USER DECLINED A SERVICE VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1