BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENEPATH

    MDR report key: 4231799 · Received October 31, 2014

    Report

    Report Number
    MW5038965
    Event Type
    Other
    Date Received
    October 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    October 31, 2014
    Manufacturer
    BIO REFERENCE LAB
    Product Code
    MVU
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HER2 FISH TESTING DONE ON RECURRENT BREAST CANCER BY GENEPATH WAS AMPLIFIED AT 3.1. TESTING ON SAME TUMOR BY FOUNDATION ONE NEXT GENERATION SEQUENCING SHOWED NO AMPLIFICATION. KNOWN TRIPLE NEGATIVE BREAST CANCER ON WHICH MULTIPLE PRIOR HER2 TESTING AND FOUNDATION TESTING CONFIRMED (BOTH PRIMARY AND OTHER RECURRENCES) AT THIS BEING HER2 NEGATIVE/NOT AMPLIFIED. BROUGHT TO ATTENTION OF OUR HOSPITAL PATHOLOGY DEPT WHO MENTIONED THIS CONFIRMED THE FOURTH PATIENT WITH FALSE HER2 POSITIVITY BY GENEPATH TESTING. THIS WOULD HAVE EXPOSED PATIENT TO SIDE EFFECTS OF HER2-TARGETED THERAPIES WITHOUT PROVIDING BENEFIT IF I HAD ACTED CLINICALLY ON THIS INFORMATION. OUR PATHOLOGY DEPARTMENT SAID THEY NOTIFIED GENEPATH WHO STOOD BY THEIR CALL. OUR PATHOLOGY IS RETESTING RUMORS THAT WERE POSITIVE OVER THE TIME-FRAME THAT THE VENDOR WAS USED HOWEVER, CALLS INTO QUESTION VALIDITY OF EITHER TEST BEING USED BY GENEPATH AND/OR INTERPRETATION OF RESULTS. IT IS NOT KNOWN IF FALSE NEGATIVES ARE ALSO AN ISSUE. HOWEVER, THIS IS A LEGAL ISSUE IN ADDITION TO PATIENT SAFETY AND OPTIMAL CARE, ESPECIALLY FOR PATIENTS WITH POTENTIALLY CURABLE CANCERS. OUR PATHOLOGY DEPARTMENT WAS USING GENEPATH FOR HER2 FISH ASSAYS FROM JANUARY 2014 THROUGH ABOUT JULY 2014. WHEN BROUGHT TO THEIR ATTENTION, OUR PATHOLOGY DEPARTMENT SWITCHED BACK TO PRIOR VENDOR FOR TESTING. IT IS NOT KNOWN TO US HOW GENEPATH IS RESPONDING TO THIS ISSUE AND POTENTIALLY HOW MANY OTHER PATIENTS (BREAST OR OTHER CANCERS ) WERE AFFECTED AND DO NOT KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698484 GENEPATH HER2 FISH ASSAY MVU BIO REFERENCE LAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR