BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1051571 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04145
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PTS WITH LOW RESULTS FOR EITHER URINE CREATININE OR URINE/CSF PROTEIN. PT 1: URINE CREATININE INITIAL RESULTS 0.2 MG/DL, REPEAT 259.3 MG/DL. URINE/CSF PROTEIN INITIAL RESULTS 1.2 MG/DL, FIRST REPEAT 169.9 MG/DL, SECOND REPEAT 172.2 MG/DL, THIRD REPEAT 576.6 MG/DL. PT 2: URINE/CSF PROTEIN INITIAL RESULTS 0.9 MG/DL, FIRST REPEAT 282.9 MG/DL, SECOND REPEAT 419.8 MG/DL. NO RESULTS WERE REPORTED FOR THESE SAMPLES FROM THE LAB. FIELD SERVICE REP FOUND THE ROOT CAUSE TO BE THE SAMPLE PROBE WHICH WAS REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK