BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3

    MDR report key: 1640924 · Received March 26, 2010

    Report

    Report Number
    2243471-2010-00010
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 22, 2010
    Report Date
    June 16, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS UNDER EVALUATION. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) OBTAINED A FAILED RESULT FOR A NEGATIVE CONTROL WITH THE KIT CAP-G CTM HIV 48 TESTS EXPT-IVD USING COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER WITH AMPLILINK SOFTWARE V. 3.2.3. THE CUSTOMER REMOVED THE RACK BEFORE THE NEGATIVE CONTROL WAS PROCESSED, WHICH CAUSED THE FAILURE. THE NEGATIVE CONTROL RESULT WAS "FAILED" AND FLAGGED WITH DISP_ERROR. AS CONFIGURED, THE AMPLILINK SOFTWARE WAS EXPECTED TO INVALIDATE ALL PATIENT SAMPLES IN THE RUN BATCH IF A CONTROL HAD A RESULT OF EITHER "FAILED" OR "INVALID." THE TEST RUN SHOULD HAVE BEEN INVALIDATED, AS THE SOFTWARE WAS CONFIGURED TO REQUIRE THAT ALL THREE CONTROLS (NEGATIVE CONTROL, LOW POSITIVE CONTROL AND HIGH POSITIVE CONTROL) MUST ALL BE VALID FOR THE RUN TO BE CONSIDERED VALID. HOWEVER, THE CUSTOMER REPORTED THAT THE FAILED NEGATIVE CONTROL DID NOT INVALIDATE THE PATIENT RESULTS. THE CUSTOMER WAS PERFORMING AN EVALUATION STUDY FOR THE CAP-CTM 48 SYSTEM. NO RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF ROCHE MOLECULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1