BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1172330 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07055
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TECHNICAL SERVICE REPRESENTATIVE REPORTED A DISCREPANT URINE TOTAL PROTEIN RESULT FOR ONE PATIENT. INITIAL RESULT WAS 2 MG/DL WITH A FLAG INSTRUCTING THE USER TO REPEAT THE SAMPLE. THE SAME SAMPLE WAS REPEATED FOUR TIMES, FIRST GIVING A RESULT THAT WAS NOT PROVIDED. THE SECOND REPEAT GAVE 93 MG/DL AND THE THIRD REPEAT GAVE 731 MG/DL, AGAIN INSTRUCTING THE USER TO REPEAT THE SAMPLE. THE FINAL RESULT (WITH DILUTION) GAVE 724 MG/DL. THE INITIAL RESULT WAS REPORTED, THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS NOT ABLE TO DUPLICATE THE DISCREPANCY OR DETERMINE THE CAUSE. HE NOTED THE CUSTOMER INDICATED THE PATIENT SAMPLE WAS THE CAUSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK