BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1722313 · Received June 14, 2010

    Report

    Report Number
    1823260-2010-03536
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER EXPERIENCED ISSUES WITH ERRATIC D-DIMER QUALITY CONTROL RESULTS AND RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.508 UG/ML WITH A DATA FLAG THAT TRIGGERED AN AUTOMATIC REPEAT OF THE SAMPLE. THE REPEAT RESULT WAS 0.378 UG/ML. THE SAMPLE WAS REPEATED ON THE OTHER C501 ANALYZER AT THE SITE, (B) (4), WITH A RESULT OF 0.520 UG/ML WITH A DATA FLAG. THE SAMPLE AUTOMATICALLY REPEATED AND A RESULT OF 0.482 UG/ML WAS GENERATED. THE RESULT OF 0.378 UG/ML WAS REPORTED. THERE WAS NO ILL EFFECT TO THE PATIENT. THE D-DIMER REAGENT LOT NUMBER WAS 62629401. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDICS FAILURE. HE ADJUSTED THE CUVETTE REGULATOR AND PERFORMED A SAMPLE PRESSURE SENSOR CHECK WITH GOOD RESULTS. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1