BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA PD-L1 (SP142) ASSAY

    MDR report key: 17173066 · Received June 21, 2023

    Report

    Report Number
    2028492-2023-00032
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 21, 2023
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    PLS
    PMA / PMN Number
    P160002
    Removal / Correction Number
    Z-0907-2023 RES91199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MATERIAL NUMBER IS NOT MARKETED OR DISTRIBUTED IN THE US. 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. THE ALLEGED SAMPLE WAS INITIALLY TESTED ON 24 FEB 2022 AND WAS REPEATED ON 21 DEC 2022 AFTER RECEIVING THE NOTIFICATION. E1 FACILITY NAME TRUNCATED DUE TO CHARACTER LIMIT: SGH - HISTOPATHOLOGY LABORATORY (B)(6) HOSPITAL PTE LTD.

    Description of Event or Problem · 0

    A CUSTOMER FROM SINGAPORE ALLEGED DISCREPANT RESULTS WITH THE VENTANA PD-L1 (SP142) ASSAY. THE ALLEGED SAMPLE INITIALLY GENERATED A NEGATIVE RESULT WHICH WAS REPORTED TO MEDICAL PERSONNEL TREATING THE PATIENT. THE SAMPLE WAS THEN RETESTED USING THE SAME ASSAY AND GENERATED A POSITIVE RESULT; THE RESULT WAS SENT TO THE CLINICIAN. TO DATE, NO HARM IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749708 VENTANA PD-L1 (SP142) ASSAY PROGRAMMED DEATH-LIGAND 1 (PD-L1) IVD, ANTIBODY PLS VENTANA MEDICAL SYSTEMS INC NA H00001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown