BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1564505 · Received December 16, 2009

    Report

    Report Number
    1823260-2009-08511
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER STATED THEY HAD A LITHIUM RESULT OF 1.5 MMOL PER L THAT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PT WAS NOT ON LITHIUM AND HAD THE PT REDRAWN. THE RESULT FROM THE REDRAW SPECIMEN WAS 0 MMOL PER L. THE USER RERAN THE ORIGINAL SERUM SPECIMEN AND RECOVERED A RESULT OF 0 MMOL PER L. THE PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE. HE INSPECTED THE C501 FOR PROPER RINSE MECHANISM ASPIRATION, DISPENSE OF THE REACTION CELLS, WASH STATION PROPER RINSE VOLUME AND ALL PROBES FOR PROPER ALIGNMENTS. HE VERIFIED THE ANALYZER PERFORMANCE WITH MECHANISM CHECKS AND HAD THE USER PERFORM CALIBRATION AND QC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR