BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1172448 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07018
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING LOW SODIUM RESULTS FOR MANY PATIENT SAMPLES. EXACT NUMBER OF SAMPLE INVOLVED IS NOT KNOWN, TWO EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 130 MMOL/L, REPEAT 143 MMOL/L. SAMPLE 2 INITIAL RESULT 129 MMOL/L, REPEATED IN THE NORMAL RANGE. NO ERRONEOUS RESULTS WERE REPORTED. USER REPLACED THE INTERNAL STANDARD, PRIMED AND RECALIBRATED THE ASSAY WHICH RESOLVED THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK