BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCHMARK GX, STAINER MODULE

    MDR report key: 19557426 · Received June 18, 2024

    Report

    Report Number
    2028492-2024-01800
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 23, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH NUMBER OF THE ANTI-ESTROGEN RECEPTOR (SP1) IS K11341 WITH AN EXPIRATION DATE OF 07-JUN-2025. THE BATCH NUMBER OF THE ANTI-PROGESTERONE RECEPTOR (1E2) IS K07998 WITH AN EXPIRATION DATE OF 25-APR-2025. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT IMPACT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. ANALYSIS OF THE REAGENT LOTS SUSPECTED DID NOT INDICATE ANY TREND IN FAILURES AT OTHER CUSTOMER SITES, THEREFORE THERE IS NO SYSTEMIC LOT ISSUE SUSPECTED WITH EITHER ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL ANTIBODY LOT K11341 OR ANTI-PROGESTERONE RECEPTOR (PR) (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY LOT K07998. IT WAS CONFIRMED DURING THE INVESTIGATION THAT BOTH ANTIBODIES WERE RELEASED WITHIN SPECIFICATIONS. IT WAS OBSERVED THAT THE REPEAT RUNS WERE NOT PERFORMED ON THE SAME INSTRUMENTS OR USING THE SAME LOTS OR DISPENSERS OF REAGENTS. NO ADDITIONAL SERVICE OR ON-SITE INVESTIGATION INFORMATION WAS AVAILABLE TO SUPPORT WHETHER THE INSTRUMENTS WERE THE SOURCE OF THE ISSUE. IT WAS REPORTED THAT ROUTINE MAINTENANCE WAS PERFORMED. THE METHOD SHEETS OF THE ER AND PR ANTIBODIES RECOMMEND ANTIBODY INCUBATION FOR 16 MINUTES WHEN USED WITH THE BENCHMARK XT. HOWEVER, IT WAS OBSERVED THAT THE CUSTOMER IS USING 32 MINUTES OF ANTIBODY INCUBATION WHICH IS CONSIDERED OFF-LABEL USE. ANY IMPROPER TISSUE HANDLING DURING FIXATION, SECTIONING, EMBEDDING, OR STORAGE THAT ALTERS ANTIGENICITY WEAKENS PROTEIN DETECTION BY THE ASSOCIATED ANTIBODY AND MAY GENERATE FALSE NEGATIVE RESULTS. ADDITIONALLY, BOTH METHOD SHEETS STATE "A NEGATIVE RESULT DOES NOT EXCLUDE THE PRESENCE OF [ER OR PR]. NEGATIVE REACTIONS IN BREAST CARCINOMA MAY BE DUE TO LOSS OR MARKED DECREASE OF EXPRESSION OF ANTIGEN. THEREFORE, IT IS RECOMMENDED THAT THIS ANTIBODY BE USED IN A PANEL OF ANTIBODIES." TISSUE STAINING IS DEPENDENT ON MANY FACTORS INCLUDING HANDLING AND PROCESSING OF THE TISSUE, FIXATION, AND TEMPERATURE FACTORS. AS DESCRIBED IN THE METHOD SHEETS, "INCONSISTENT RESULTS MAY BE A CONSEQUENCE OF VARIATIONS IN FIXATION AND EMBEDDING METHODS, OR FROM INHERENT IRREGULARITIES WITHIN THE TISSUE." "AS WITH ANY IHC TEST, A NEGATIVE RESULT MEANS THAT THE ANTIGEN WAS NOT DETECTED, NOT THAT THE ANTIGEN WAS ABSENT IN THE CELLS OR TISSUE ASSAYED." PRE-ANALYTIC HANDLING OF THE SLIDE ITSELF AND/OR SLIDE SURFACE CHEMISTRY ISSUES RELATED TO THE GLASS SLIDE CANNOT BE RULED OUT AS POTENTIAL CAUSAL FACTORS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ANTI-ESTROGEN RECEPTOR (SP1) (ER) /ANTI-PROGESTERONE RECEPTOR (1E2) (PR) ANTIBODY RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES TESTED ON A BENCHMARK GX, STAINER MODULE INSTRUMENT. THE ALLEGED PATIENT SAMPLES WERE REPORTEDLY STAINED AS NEGATIVE. ONE PATIENT WAS A TRIPLE NEGATIVE BREAST CANCER PATIENT WHO ALLEGEDLY RECEIVED CHEMOTHERAPY. THIS PATIENT ALSO ALLEGEDLY HAD SURGERY AT ANOTHER BREAST CENTER WHERE THE SAMPLE WAS CONSIDERED POSITIVE FOR ER/PR. THE INITIAL PATIENT¿S SAMPLE WAS THEN RETESTED AND WAS FOUND TO BE POSITIVE. 4 MORE PATIENT SAMPLES WERE REPEATED AND FOUND TO BE DISCREPANT FROM THE INITIAL TESTING RESULTS. 2 PATIENTS ALLEGEDLY DID NOT RECEIVE CHEMOTHERAPY BUT WERE STATED TO HAVE UNDERGONE BREAST SURGERY AT ANOTHER BREAST CENTER. THE TREATMENT WAS ALLEGEDLY CORRECT. THE SAMPLES WERE REPEATED AND WERE FOUND TO BE POSITIVE. IT IS SUSPECTED BY THE LABORATORY (NOT CONFIRMED) THAT THE OTHER TWO PATIENTS DID NOT RECEIVE THERAPY. THERE IS NO INFORMATION ABOUT THESE SUSPECT PATIENTS' SAMPLES OR RETEST RESULTS. THERE ARE NO REPORTS ABOUT THE DETERIORATION OF THE PATIENT'S HEALTH, THE TIMELINE FOR THE SUSPECTED ERRONEOUS RESULTS, OR PATIENT-SPECIFIC TREATMENT PLANS OR OUTCOMES. FURTHER INFORMATION WAS ALREADY REQUESTED. THIS MDR IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337445 BENCHMARK GX, STAINER MODULE SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other