BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK XT STAINING MODULE

    MDR report key: 4140491 · Received September 30, 2014

    Report

    Report Number
    2028492-2014-00004
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 17, 2014
    Report Date
    September 29, 2014
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VENTANA MEDICAL SYSTEMS, INC. RECEIVED REPLACED INSTRUMENT PARTS BACK FOR ANALYSIS. A REPRESENTATIVE RETAINED SAMPLE OF CYTOKERATIN 5/6 WAS USED. THE PARTS AND THE REAGENT KIT ARE PERFORMING AS LABELED. NO FAILURE MODE HAS BEEN ISOLATED. THE REAGENT KIT THE CUSTOMER WAS USING HAS NOT BEEN RETURNED FOR EVALUATION. THE PATIENT IS ON CORRECT THERAPY ACCORDING TO THE CUSTOMER, AS OF (B)(6) 2014. RETURNED PART EVALUATION SHOWS NO INSTRUMENT-RELATED CONTRIBUTION TO THE NEGATIVE RESULT AT THIS TIME. ROCHE SERVICE ORGANIZATION WILL ENCOURAGE THE CUSTOMER TO CONDUCT TIMELY PRE-CHECKS OF ALL NECESSARY PARAMETERS BEFORE RUNNING PATIENT SPECIMENS. THIS IS THE FINAL REPORT. NO FURTHER INFORMATION TO BE PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER DIAGNOSED A NEGATIVE PATIENT RESULT USING CYTOKERATIN 5/6 ON (B)(6) 2014, USING BENCHMARK XT. PATIENT WAS PRESCRIBED FOR THERAPY. ON (B)(6) 2014, CUSTOMER ABORTED FURTHER STAINING RUNS AFTER REALIZING THEY HAD NEGATIVE RESULTS FROM THE (B)(6). TREATMENT THAT WAS PRESCRIBED ON THE (B)(6) WAS SUSPENDED. AFTER A REPAIR VISIT BY THE SERVICE ENGINEER, WHERE SEVERAL INSTRUMENT PARTS SUSPECTED OF LEAKING OR NOT SENDING A SIGNAL WERE REPLACED, THE CUSTOMER RE-RAN THE PATIENT SPECIMENS AND FOUND THEM POSITIVE. TYPE OF TREATMENT WAS THEN CHANGED, ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608133 BENCHMARK XT STAINING MODULE BENCHMARK XT KPA VENTANA MEDICAL SYSTEMS, INC. 05265231001

    Patients

    Seq Age Sex Outcome Treatment
    1