BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1448766 · Received April 29, 2009

    Report

    Report Number
    1823260-2009-03043
    Event Type
    Malfunction
    Date Received
    April 29, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND WAS UNABLE TO DETERMINE A CAUSE. HE RAN A PRECISION AND CHECK TEST WITH RESULTS WITHIN ACCEPTABLE LIMITS. THE USER RAN CALIBRATION AND QC WITH RESULTS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE USER HAD ONE PATIENT SAMPLE FOR AMMONIA THAT RESULTED AT 37.6 UMOL PER L WITH A DATA FLAG AND REPEATED AT 19 UMOL PER L WITH A DATA FLAG. THE SAMPLE WAS RERUN ON THE INTEGRA WITH A RESULT OF OVER 60 UMOL PER L (NO SPECIFIC RESULT PROVIDED). THE USER THEN RERAN THE SAMPLE AS A DECREASED SAMPLE VOLUME ON THIS C501 AND RECOVERED A RESULT OF 31.6 UMOL PER L. THE INTEGRA RESULT WAS THE ONLY RESULT REPORTED.

    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