BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA PD-L1 (SP142) ASSAY

    MDR report key: 16418777 · Received February 22, 2023

    Report

    Report Number
    2028492-2023-00019
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 22, 2023
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    PLS
    PMA / PMN Number
    P160002
    Removal / Correction Number
    2028492-11-09-2022-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE REAGENT LOT NUMBER WAS NOT PROVIDED, HOWEVER, ROCHE OBSERVED UNACCEPTABLE, LIGHT STAINING WITH SOME VENTANA PD-L1 (SP142) ON-MARKET LOTS, DURING INTERNAL COMPARISON STUDIES. LIGHT STAINING AFFECTS THE BORDERLINE OF POSITIVE VERSUS NEGATIVE TEST RESULTS. AN ON-GOING INVESTIGATION HAS DETERMINED THE ROOT CAUSE IS RELATED TO VARIABILITY IN THE SELECTION OF ANTIBODY CONCENTRATION IN RAW MATERIALS, AFFECTING SPECIFIC VENTANA PD-L1 (SP142) ASSAY LOTS MADE WITH THE IMPACTED RAW MATERIALS. A NOTIFICATION HAS BEEN SENT TO US CUSTOMERS INFORMING THEM OF THE ISSUE TO IMMEDIATELY DISCONTINUE THE USE OF AND DISCARD ANY REMAINING INVENTORY OF SPECIFIC IMPACTED LOTS AND INFORMING OF AN UPDATED DATE OF EXPIRATION FOR CERTAIN LOTS.

    Description of Event or Problem · 0

    A CUSTOMER FROM JAPAN STATED THEY INITIALLY RECEIVED NEGATIVE RESULTS FOR THREE BREAST CANCER SAMPLES TESTED WITH THE VENTANA PD-L1 (SP142) ASSAY. THESE SAMPLES WERE REPEATED AND OF THESE, 1 REPEATED WITH A POSITIVE RESULT. THE INITIAL NEGATIVE RESULT FOR THIS SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. THE CUSTOMER CONCLUDED THAT THE OUTCOME WOULD NOT AFFECT THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407852 VENTANA PD-L1 (SP142) ASSAY PROGRAMMED DEATH-LIGAND 1 (PD-L1) IVD, ANTIBODY PLS VENTANA MEDICAL SYSTEMS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown