BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA ANTI-MLH1 (M1) MOUSE MONOCLONAL PRIMARY ANTIBODY

    MDR report key: 16547585 · Received March 15, 2023

    Report

    Report Number
    2028492-2023-00022
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    January 9, 2023
    Report Date
    April 6, 2023
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    QNH
    PMA / PMN Number
    P210001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE MLH1 (M1) MM PAB-US EXPORT (CATALOG NO: 08033668001; UDI: (B)(4)) WHICH IS EQUIVALENT TO THE US KIT; MLH1 (M1) MOUSE MONOCLONAL PAB US (CATALOG NO: 07862237001; UDI: (B)(4)).

    Additional Manufacturer Narrative · 0

    THE DEVICE CODE WAS UPDATED. THE CUSTOMER'S SLIDE IMAGES WERE REQUESTED FOR REVIEW BUT WERE NOT PROVIDED. A REVIEW OF THE MLH1 PROTOCOL REPORT FROM THE CUSTOMER¿S HOST COMPUTER INDICATES THAT THE CUSTOMER WAS NOT USING THE PACKAGE INSERT RECOMMENDED PROTOCOL WHEN THE AFFECTED SLIDES WERE STAINED. THE CUSTOMER DECREASED THE ANTIGEN RETRIEVAL TIME AND DECREASED THE PRIMARY ANTIBODY INCUBATION TIME. PRODUCT LABELING STATES: "THIS ANTIBODY HAS BEEN OPTIMIZED FOR SPECIFIC INCUBATION TIMES, BUT THE USER MUST VALIDATE RESULTS OBTAINED WITH THIS REAGENT. THE EFFECT OF VARYING TIME AND TEMPERATURE OF THE ANTIGEN RETRIEVAL (CELL CONDITIONING) AND ANTIBODY INCUBATION FROM THE RECOMMENDED STAINING PROTOCOL MAY RESULT IN SUB OPTIMAL STAINING AND FALSE MMR RESULTS. IT IS STRONGLY RECOMMENDED NOT TO DEVIATE FROM THE RECOMMENDED STAINING PROTOCOL. APPROPRIATE CONTROLS SHOULD BE EMPLOYED AND DOCUMENTED. USERS WHO DEVIATE FROM THE LISTED PROTOCOL MUST ACCEPT RESPONSIBILITY FOR INTERPRETATION OF PATIENT RESULTS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    A CUSTOMER FROM IRELAND ALLEGED DISCREPANT RESULTS FOR 4 PATIENT SAMPLES USING THE VENTANA ANTI-MLH1 (M1) MOUSE MONOCLONAL PRIMARY ANTIBODY. THE FIRST TWO SAMPLES WERE RUN THE WEEK OF (B)(6) 2023: TWO ALLEGED SAMPLES INITIALLY PRODUCED POSITIVE STAINING RESULTS WHICH WERE REPORTED TO MEDICAL PERSONNEL. THE NEXT TWO SAMPLES WERE RUN THE WEEK OF (B)(6) 2023: THE STAINING RESULTS FOR THE OTHER TWO ALLEGED SAMPLES WERE REPORTED TO MEDICAL PERSONNEL AS "UNINTERPRETABLE." THE HYPERMETHYLATION TESTING RESULTS FOR ALL 4 PATIENT SAMPLES INDICATED THAT THE MLH-1 STAINING SHOULD HAVE BEEN NEGATIVE. THE CUSTOMER STATED THE ON-SLIDE CONTROLS STAINED AS EXPECTED. TO DATE, NO HARM OR INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711207 VENTANA ANTI-MLH1 (M1) MOUSE MONOCLONAL PRIMARY ANTIBODY IMMUNOHISTOCHEMISTRY TEST, DNA MISMATCH REPAIR (MMR) PROTEIN ASSAY QNH VENTANA MEDICAL SYSTEMS INC NA J21229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown