BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL ADVANCE

    MDR report key: 3891441 · Received June 18, 2014

    Report

    Report Number
    1217183-2014-00004
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K002400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACL ADVANCE INSTRUMENT BACKUP WAS RECEIVED FROM THE CUSTOMER, CONTAINING DATA FROM THE INCORRECT DATES (B)(6) THE ISSUE OCCURRED AROUND (B)(6). THEREFORE, THE DATABASE BACKUP DID NOT INCLUDE RELEVANT INFORMATION TO HELP THE INVESTIGATION. IL HAS ATTEMPTED TO REPRODUCE THE PROBLEM MULTIPLE TIMES WITH NO SUCCESS. WE HAVE TRIED THE SCENARIO AS DESCRIBED IN THIS COMPLAINT, AS WELL AS USING DIFFERENT COMBINATIONS TO INTERRUPT THE INSTRUMENT DURING OPERATION. IN PARALLEL, THE SOFTWARE DEVELOPMENT TEAM REVIEWED THE INSTRUMENT SOFTWARE CODE, CONCENTRATING ON TWO FUNCTIONAL AREAS: ENTERING SAMPLE RACKS WITH THE BAR CODE READER ON (PRESS THE F2 KEY FROM ORDERS SCREEN), INITIATING A RUN (PRESS THE F3 KEY FROM THE ORDERS SCREEN). NEITHER CODE REVIEW WAS SUCCESSFUL IN UNCOVERING CODE ABNORMALITIES. IL IS CONTINUING TO REQUEST MORE INFORMATION FROM THE CUSTOMER INCLUDING: BARCODE FORMAT USED AND OTHER TESTS ORDERED TO ENABLE IL TO REPRODUCE THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THEIR ACL ADVANCE HAS CHANGED SAMPLE IDS FOR TWO PATIENTS. THE SAMPLE'S WERE BARCODED INTO THE INSTRUMENT AND THE CORRECT SAMPLE IDS WERE RECORDED. WHEN THE CUSTOMER BEGAN THE TEST THE INSTRUMENT CHANGED THE SAMPLE ID TO A NUMBER WHICH WAS RUN PREVIOUSLY. SAMPLE ID, (B)(6) WAS SCANNED ON (B)(6) AT APPROXIMATELY 20:00 FOR HEMOSIL RECOMBIPLASTIN 2G (PT REAGENT). THE SAMPLE ID WAS CHANGED BY THE INSTRUMENT TO 62712, WHICH HAD BEEN RUN ON (B)(6) FOR HEMOSIL RECOMBIPLASTIN 2G. THE TEST RAN TO COMPLETION, BUT THE TECHNOLOGIST CAUGHT THE DISCREPANCY AND THE RESULT WAS NOT REPORTED. SAMPLE ID (B)(6) WAS SCANNED ON (B)(6) AT APPROXIMATELY 20:00 FOR HEMOSIL RECOMBIPLASTIN 2G. THE SAMPLE ID WAS CHANGED BY THE INSTRUMENT TO 62717, WHICH HAS BEEN RUN ON (B)(6) FOR HEMOSIL RECOMBIPLASTIN 2G. AT THAT POINT, THE TECHNOLOGIST ABORTED THE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359323 ACL ADVANCE COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 9990-11

    Patients

    Seq Age Sex Outcome Treatment
    1