BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2036611 · Received April 1, 2011

    Report

    Report Number
    1823260-2011-01827
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 14, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. IT WAS NOTED THE CUSTOMER WAS USING 13 MM DIAMETER TUBES WITHOUT TUBE ADAPTERS. DUE TO INSUFFICIENT DATA, NO FURTHER INVESTIGATION WAS POSSIBLE. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS BEEN RECEIVING QUESTIONABLY LOW RESULTS FOR MULTIPLE REAGENTS ON THEIR COBAS C501 ANALYZER. THE CUSTOMER RECEIVED A DISCREPANT ALBUMIN GEN.2 RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER REPEATED THE TEST ON THE SAME ANALYZER AND REPORTED THOSE RESULTS OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 0.1G/DL. THE REPEAT RESULT WAS 4.4 G/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE LOT NUMBER OF THE REAGENT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE OF THIS EVENT. HE CLEANED AND CHECKED THE SAMPLE ALIGNMENT OF THE PROBES. HE RAN PRECISION CHECK ON THE ANALYZER WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE COBAS 6000 C501 MODULE CJW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1