BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEN ANTI-HER2/NEU [4B5] RM PAB-US EXPORT

    MDR report key: 23807339 · Received December 15, 2025

    Report

    Report Number
    2028492-2025-05111
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    April 24, 2025
    Report Date
    January 9, 2026
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    NJT
    PMA / PMN Number
    EXPORT ONLY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN AN UPDATED COMMUNICATION RECEIVED ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED VIA BIOPSY ON (B)(6) 2025. A CHEMOTHERAPY REGIMEN (QMT) COMPRISING TCHP (TAXOTERE/DOCETAXEL, CARBOPLATIN, HERCEPTIN/TRASTUZUMAB, AND PERJETA/PERTUZUMAB) WAS INITIATED ON (B)(6) 2025 AND COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALL DESCRIBED SIDE EFFECTS OF THE TREATMENT, THOUGH NO HOSPITALIZATION WAS REPORTED; ADDITIONAL CARE CONSISTED OF EMERGENCY ROOM AND EXTRA ONCOLOGY VISITS. SURGERY WAS PERFORMED ON (B)(6) 2025, AND IHC TESTING WAS CONDUCTED ON THE SURGICAL SPECIMEN. THE BIOPSY BLOCK WAS SUBSEQUENTLY SENT TO THE CUSTOMER SITE FOR FURTHER EXAMINATION, WHERE IHC AND FISH TESTING WERE REPEATED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT HAS RECEIVED RADIOTHERAPY AND DOES NOT REQUIRE SURGERY. IN A FOLLOW-UP COMMUNICATION RECEIVED FROM THE CUSTOMER PATHOLOGIST, IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025. ADDITIONAL TESTING WAS PERFORMED ON THE UNIDENTIFIED SPECIMEN COLLECTED DURING THIS PROCEDURE, AND THE APPROPRIATE TREATMENT COURSE WAS IDENTIFIED FOR THE PATIENT. MULTIPLE ATTEMPTS OF COMMUNICATION WERE MADE TO OBTAIN THE OFFICIAL STATUS AND IMPACT OF THE IDENTIFIED PATIENT. THE CAUSE OF THE INITIAL STAINING DISCREPANCY ON-SITE IS RELATED TO THE CUSTOMER'S LABORATORY PROCEDURE, WHICH HAS BEEN CORRECTED BY ON-SITE ROCHE SUPPORT UPON DISCOVERY. THERE IS NO INFORMATION TO REASONABLY SUGGEST A DEVICE MALFUNCTION AGAINST A ROCHE-MANUFACTURED PRODUCT.

    Additional Manufacturer Narrative · 0

    THE EXPIRATION DATE OF REAGENT LOT N03982 IS 05-SEP-2026. THE EXPIRATION DATE OF REAGENT LOT N12098 IS 22-DEC-2026. THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). A REVIEW OF INTERNAL RELEASE DATA CONFIRMED THAT REAGENT LOTS N03982 AND N12098 WERE COMPLIANT WITH ALL QUALITY CRITERIA AT THE TIME OF RELEASE. ADDITIONALLY, NO NON-CONFORMANCES RELATED TO THE ALLEGATION WERE IDENTIFIED DURING THE FINAL INSPECTION OF THE PRODUCTS. A REVIEW OF THE CUSTOMER PROTOCOL NOTES THAT THE CUSTOMER IS USING A MODIFIED PROTOCOL, EMPLOYING A PREP-KIT DISPENSER. IT IS REPORTED THAT THE CUSTOMER TRANSFERS THE VOLUME OF THE VEN ANTI-HER2/NEU (4B5) RM PAB-US EXPORT REAGENT INTO THE PREP-KIT TO DILUTE WITH THE ANTIBODY DILUENT PRODUCT IN A MODIFIED PROTOCOL. THIS IS CONSIDERED OFF-LABEL USE OF THE ASSAY, AS THE VENTANA PRE-FILLED DISPENSERS HAVE BEEN FILLED TO ALLOW A SUFFICIENT NUMBER OF TESTS. THE PRODUCT LABELING STATES: "NO RECONSTITUTION, MIXING, DILUTION, OR TITRATION IS REQUIRED. FURTHER DILUTION MAY RESULT IN LOSS OF ANTIGEN STAINING. THE USER MUST VALIDATE ANY SUCH CHANGES." FURTHER, THE LABELING STATES THAT DIFFERENCES IN TISSUE PROCESSING AND TECHNICAL PROCEDURES IN THE LABORATORY MAY PRODUCE SIGNIFICANT VARIABILITY IN RESULTS AND REQUIRE REGULAR USE OF CONTROLS. THE INVESTIGATION DETERMINED THAT THE DISCREPANCIES WERE ATTRIBUTED TO IMPROPER USE OF A PREP KIT IN IHC PROCEDURES. NO PRODUCT PROBLEM WAS IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT STAINING PRODUCED WITH THE VEN ANTI-HER2/NEU [4B5] RM PAB-US EXPORT ASSAY FOR A PATIENT SAMPLE TESTED ON A BENCHMARK GX SYSTEM. THE PATIENT'S RESULTS USING THE IMMUNOHISTOCHEMISTRY (IHC) BREAST PANEL WITH THE CURRENT ASSAY WERE ER+, PR+, KI67, AND HER2 3+. REPORTEDLY, BASED UPON THESE FINDINGS, TREATMENT (DETAILS UNKNOWN) WAS ADMINISTERED. THE PATIENT REPORTEDLY DID NOT TOLERATE THE TREATMENT VERY WELL, AND IT WAS INTERRUPTED HALFWAY THROUGH. THE SAME TISSUE BLOCK WAS STAINED WITH IHC AT A DIFFERENT HOSPITAL, AND THE RESULT WAS HER2 NEGATIVE. ON (B)(6) 2025, THE TISSUE BLOCK WAS THEN SENT BACK TO THE CUSTOMER SITE, WHERE A DUAL ISH (IN SITU HYBRIDIZATION) TEST WAS PERFORMED, AND THE RESULT WAS NON-AMPLIFIED. THE PATIENT SUBSEQUENTLY RECEIVED RADIOTHERAPY AND DID NOT REQUIRE SURGERY. THERE IS NO INFORMATION IN REGARD TO THE ADVERSE REACTION THAT THE PATIENT HAD TO THE TREATMENT. ALSO, THE TIME DIFFERENCE BETWEEN INITIAL AND REPEAT TESTING IS NOT KNOWN. THE PATIENT IS CURRENTLY WELL. DESPITE MULTIPLE ATTEMPTS, NO FURTHER INFORMATION RELATED TO THE PATIENT, INCLUDING ASSOCIATED TREATMENT(S), THE PATIENT'S DEMOGRAPHIC, CLINICAL STATUS, AND CLINICAL HISTORY, COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765640 VEN ANTI-HER2/NEU [4B5] RM PAB-US EXPORT IMMUNOHISTOCHEMISTRY REAGENTS AND KITS NJT VENTANA MEDICAL SYSTEMS INC. N03982, N12098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention