BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK XT AUTOMATED SLIDE STAINER

    MDR report key: 2417948 · Received December 20, 2011

    Report

    Report Number
    2028492-2011-00004
    Event Type
    Malfunction
    Date Received
    December 20, 2011
    Date of Event
    October 11, 2011
    Report Date
    December 15, 2011
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISCOVERY BY THE INSTRUMENT USER THAT THIS DEVICE WAS NOT STAINING CONSISTENTLY, VENTANA SERVICE PERSONNEL WERE CALLED IN TO DIAGNOSE AND CONDUCT REPAIRS. THE INSTRUMENT WAS REPAIRED AND RETURNED TO SERVICE ON (B)(4) 2011. THE FAILED PARTS HAVE NOT BEEN RECEIVED FOR EVALUATION AS OF THE DATA OF THIS REPORT. THIS PARTICULAR CUSTOMER DOES NOT HAVE A CURRENT SERVICE CONTRACT FOR THE INSTRUMENT WITH VENTANA MEDICAL SYSTEMS, INC. IT WAS ALSO DETERMINED BY THE USER THAT A PT BIOPSY TISSUE STAINED PREVIOUSLY ON THIS INSTRUMENT PRODUCED A FALSE NEGATIVE INDICATION FOR THE HELICOBACTER PYLORI DIAGNOSTIC MARKER WHICH WAS THEN REPORTED TO THE PT'S PHYSICIAN. THERE WAS NO SERIOUS HARM TO THE PT AS A RESULT OF THIS FALSE NEGATIVE RESULT FOR HELICOBACTER PYLORI BEING ROTTED TO THE PHYSICIAN AND THE RESULTANT DELAY IN THERAPY. THE INITIAL REPORTER HAS EVALUATED WHETHER THERE WERE ANY OTHER ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY DURING THE TIMEFRAME WHEN THE BENCHMARK XT SERIAL NUMBER (B)(4) WAS POTENTIALLY STAINING TISSUE SLIDES INCONSISTENTLY. AS OF THE DATE OF THIS REPORT THE INITIAL REPORTER HAS INDICATED THAT THERE WERE NO OTHER ERRONEOUS RESULTS RESULTING FROM THIS EQUIPMENT ISSUE REPORTED OUT OF THEIR LABORATORY.

    Description of Event or Problem · 1

    A FALSE NEGATIVE DIAGNOSTIC TISSUE RESULT WAS REPORTED OUT OF A CLINICAL LABORATORY TO A PT'S PHYSICIAN FOR HELICOBACTER PYLORI. THIS DIAGNOSTIC TEST WAS RUN ON A VENTANA BENCHMARK XT AUTOMATED SLIDE STAINING INSTRUMENT. THIS FALSE NEGATIVE RESULT BEING REPORTED OUT CAUSED A DELAY IN THERAPY FOR THE AFFECTED PT. THE ORIGINAL RESULT WAS NOT NOTED AS ERRONEOUS. AN ISSUE WITH INSTRUMENT PERFORMANCE DISCOVERED AT A LATER DATE RESULTED IN A DECISION TO RETEST THIS TISSUE SAMPLE AND THE RESULT WAS POSITIVE FOR THE SAME PT TISSUE UPON RETEST. THE CAUSE OF THE ORIGINAL FALSE NEGATIVE RESULT WAS IDENTIFIED AS MECHANICAL, INCLUDING A CRACKED VORTEX AIR MIXER AND A DEFECTIVE REACTION BUFFER VALVE IN THE BENCHMARK XT INSTRUMENT. WITHOUT THESE COMPONENTS FUNCTIONING AS INTENDED, EXPOSURE OF TISSUE MOUNTED ON SLIDES TO PROTOCOL-SPECIFIC REAGENTS MAY NOT BE CONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCHMARK XT AUTOMATED SLIDE STAINER BENCHMARK XT KPA VENTANA MEDICAL SYSTEMS, INC. 05265231001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONFIRM ANTI-HELICOBACTER PYLORI (SP48)| RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA| CAT #790-4374