BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1964070 · Received January 19, 2011

    Report

    Report Number
    1823260-2011-00282
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 25, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT DETERMINED. THE CUSTOMER WAS EDUCATED REGARDING PROPER PRODUCT HANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER HAD ON-GOING C-REACTIVE PROTEIN GEN.3 (CRP) CALIBRATION ISSUES AND RECEIVED QUESTIONABLE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. SHE PROVIDED CRP RESULTS FOR THREE PATIENT SAMPLES, RESULTS FOR ONE PATIENT WERE DISCREPANT. BOTH INITIAL AND REPEAT TESTING WERE PERFORMED ON THE SAME COBAS 6000 C501 ANALYZER. THE INITIAL RESULT WAS 102.72 MG/L. THE SAMPLE WAS REPEATED ON (B)(6) 2010 AND RECOVERED 23.11 MG/L. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY, NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE CRP REAGENT LOT NUMBER WAS 63067501. THE CUSTOMER BELIEVED A POSSIBLE CAUSE OF THE ISSUE MAY HAVE BEEN IMPROPER CALIBRATOR HANDLING (INCLUDING NOT USING THE CORRECT CALIBRATOR OR INADEQUATE CALIBRATOR VOLUME). ANOTHER POSSIBLE CAUSE WAS A SOFTWARE ISSUE WHICH WOULD ACCOUNT FOR THE MISSING K FACTOR. IMPROPER DATA MANAGEMENT COULD LEAD TO A SOFTWARE ISSUE. ACCORDING TO THE CUSTOMER, CRP CALIBRATION AND QUALITY CONTROL WERE NOT PERFORMED PRIOR TO TESTING THE PATIENT SAMPLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1