BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATHWAY HER2 (4B5)

    MDR report key: 12724503 · Received October 29, 2021

    Report

    Report Number
    2028492-2021-00007
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    January 5, 2021
    Report Date
    October 29, 2021
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVC
    UDI-DI
    04015630972197
    PMA / PMN Number
    P990081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM THE UNITED STATES ALLEGED AN IMPACT TO PATIENT TREATMENT BASED ON FALSE NEGATIVE RESULTS FOR A PATIENT SAMPLE STAINED WITH PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY TEST. AN INVESTIGATION WAS PERFORMED TO EVALUATE THE CUSTOMER ISSUE. NO PRODUCT PROBLEM WAS IDENTIFIED. REVIEW OF THE BATCH MONITORING DASHBOARD INDICATED THAT ALLEGED LOT WAS COMPLIANT WITH ALL QUALITY CRITERIA AT THE TIME OF RELEASE. FURTHERMORE, PER THE CUSTOMER REPORT, THE ALLEGED LOT WAS USED TO COMPLETION AND DID NOT PRODUCED ERRONEOUS RESULTS ANY OTHER TIME. ADDITIONAL INFORMATION SUCH AS PATIENT'S TREATMENT OUTCOME AS WELL AS CURRENT TREATMENT BASED ON UPDATED HER-2 RESULTS, OR STAINING IMAGES OF THE INITIAL AND RETEST RESULTS, HAS BEEN REQUESTED BUT NOT PROVIDED. THE CUSTOMER INDICATED THAT ALTHOUGH THE CONTROLS CONTAINING POSITIVE AND NEGATIVE BREAST TISSUE ARE CUT AHEAD OF TIME, EVERY TWO WEEKS, AND ARE STORED ON THE COUNTER PRESENTLY, HOWEVER THEY WERE PREVIOUSLY STORED IN THE REFRIGERATOR. PER THE PRODUCT METHOD SHEET - POSITIVELY CHARGED SLIDES MAY BE SUSCEPTIBLE TO ENVIRONMENTAL STRESSES RESULTING IN INAPPROPRIATE STAINING OF ANY IHC ASSAY (FOR EXAMPLE, LACK OF PRIMARY ANTIBODY OR COUNTERSTAIN ON THE TISSUE. BASED ON THE AVAILABLE INFORMATION, STORAGE OF THE INITIAL CONTROL SLIDES IN THE REFRIGERATOR, MOST LIKELY ADVERSELY IMPACTED SLIDE FLUIDICS AND THEREFORE IS THE MOST LIKELY CONTRIBUTING FACTOR OF THE ALLEGED ISSUE. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER FROM THE UNITED STATES ALLEGED AN IMPACT TO PATIENT TREATMENT BASED ON FALSE NEGATIVE RESULTS FOR A PATIENT SAMPLE STAINED WITH PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY TEST. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT A NEEDLE & SKIN PUNCH BIOPSY IN (B)(6) 021 FOR COLLECTION OF TISSUE SAMPLE FOR TESTING. ON (B)(6) 2021, PATIENT'S PRIMARY BREAST TUMOR SAMPLE WAS TESTED, YIELDING NEGATIVE HER-2 RESULT. THE NEGATIVE RESULTS WERE RELEASED TO THE PATIENT'S TREATING PHYSICIAN. THE PATIENT'S INITIAL DIAGNOSIS WAS REPORTEDLY INVASIVE DUCTAL CARCINOMA AND THE PATHOLOGIST ONSITE STATED THAT THE PATIENT HAD CHEMOTHERAPY WITH PATHOLOGIC COMPLETE RESPONSE, CLINICALLY RESPONDED ON RADIOLOGY. ON (B)(6) 2021, THE PATIENT HAD A DOUBLE MASTECTOMY, INCLUDING LYMPH NODES, RIGHT AXILLARY REGIONAL RESECTIONS. NO RESIDUAL DISEASE WAS DETECTED AFTER MASTECTOMY IN BREAST AND AXILLARY LYMPH NODES. HOWEVER, A REPEAT PET SCAN INDICATED THE PRESENCE OF RESIDUAL LESIONS IN THE AXILLARY. THEREFORE, ON (B)(6) 2021, PATIENT'S BREAST LYMPH NODE SAMPLE WAS TESTED, YIELDING A POSITIVE HER-2 RESULT. THE INITIAL PRIMARY TUMOR SAMPLE WAS THEN REPEAT TESTED, THIS TIME YIELDING A POSITIVE HER-2 RESULT. PLEASE NOTE, BREAST MARKERS WERE NOT RUN ON THE LYMPH NODE SAMPLE DURING INITIAL TESTS ON (B)(6) 2021. ALSO, NO ER/PR TESTS DONE ON THE PRIMARY TUMOR SAMPLE DURING REPEAT TESTS IN (B)(6) 2021, ONLY HER-2 TEST WAS REPEATED ON THIS SAMPLE. THE PATIENT'S FINAL DIAGNOSIS WAS METASTATIC BREAST CANCER. THE CUSTOMER ADDITIONALLY ALLEGED THAT ALTHOUGH THE PATIENT RECEIVED CHEMOTHERAPY, THEY DID NOT RECEIVE HERCEPTIN AS PART OF TREATMENT DUE TO THE INITIAL HER-2 NEGATIVE RESULTS. PLEASE NOTE THAT THERE IS NO INFORMATION REGARDING THE PATIENT'S TREATMENT OUTCOME FROM THE TREATING PHYSICIAN. THE CUSTOMER COMMUNICATED THAT ON (B)(6) 2021 THERE WAS AN AMENDMENT TO UPDATE THE HER-2 TEST RESULTS (NEGATIVE/0 TO POSITIVE/3+), BUT WITH NO CHANGE IN DIAGNOSIS. AN INVESTIGATION WAS PERFORMED TO EVALUATE THE CUSTOMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616856 PATHWAY HER2 (4B5) SYSTEM, TEST, HER-2/NEU, IHC MVC VENTANA MEDICAL SYSTEMS, INC. NA G23061 04015630972197

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other