BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINTEC PLUS CYTOLOGY

    MDR report key: 18748298 · Received February 21, 2024

    Report

    Report Number
    2028492-2024-00504
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 23, 2024
    Report Date
    May 15, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    QKF
    PMA / PMN Number
    P190024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN A SUBSEQUENT COMMUNICATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2024, BIOPSIES WERE ALLEGEDLY TAKEN FROM THE PATIENTS. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN FURTHER PATIENT INFORMATION. THIS ALLEGATION WAS REVIEWED BY A ROCHE PHYSICIAN. THE DECISION TO COMPLETE SUCH A PROCEDURE IS ALWAYS MADE IN THE CONTEXT OF THE PATIENT'S HISTORY AND THE CLINICIAN'S EXAM. A BIOPSY IS ONLY PERFORMED BASED ON THE TREATING PHYSICIAN'S CLINICAL JUDGMENT AND DIRECT VISUAL EXAMINATION OF THE PATIENT. THIS DECISION IS AIDED BY THE RESULTS OF THE CINTEC PLUS CYTOLOGY TESTING, BUT THE CINTEC PLUS CYTOLOGY DOES NOT DIRECT PATIENT CARE, THE PHYSICIAN DOES. AT THIS TIME, THERE IS NO INFORMATION TO REASONABLY SUGGEST HARM OR SERIOUS INJURY OCCURRED AS A RESULT OF THE CINTECH PLUS CYTOLOGY RESULTS. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE CUSTOMER RETURNED POSITIVE SLIDES SHOWED UNACCEPTABLE RED BACKGROUND CONCENTRATED AROUND THE NUCLEUS OF THE SQUAMOUS CELLS, WHICH MAY HAVE BEEN INTERPRETED AS A POTENTIAL POSITIVE RESULT. NOTE, IF A SLIDE HAS UNACCEPTABLE BROWN AND/OR RED BACKGROUND THAT INTERFERES WITH STAINING INTERPRETATION, THE SLIDE SHOULD BE DEEMED UNSATISFACTORY. THE INVESTIGATION INTO THE COMPLAINT LOT K15868 SHOWED RED BACKGROUND STAINING LOCALIZED AROUND THE NUCLEUS OF SQUAMOUS CELLS WITH THE CINTEC® PLUS CYTOLOGY PMA ASSAY WHICH COULD POTENTIALLY MIMIC A DUAL-POSITIVE SIGNAL. ROCHE HAS ADVISED CUSTOMERS TO DISCONTINUE THE USE OF AND DISCARD ANY REMAINING INVENTORY OF THE CINTEC® PLUS CYTOLOGY PMA, LOT K15868. ALTHOUGH A FALSE POSITIVE CINTEC® PLUS CYTOLOGY RESULT COULD LEAD TO AN UNNECESSARY MEDICAL PROCEDURE (COLPOSCOPY) AND ITS ASSOCIATED EFFECTS, A BIOPSY IS ONLY PERFORMED BASED ON THE TREATING PHYSICIAN¿S DIRECT VISUAL INSPECTION AND CLINICAL JUDGMENT OF THE PATIENT'S CLINICAL HISTORY AND, AGAIN, NOT SOLELY BASED ON THE CINTEC® PLUS CYTOLOGY RESULT. THE IMPACT OF THE ISSUE MAY BE MITIGATED FOLLOWING THE GUIDANCE OUTLINED IN THE CINTEC® PLUS CYTOLOGY PMA METHOD SHEET AND THE ASSAY¿S INTERPRETATION GUIDE. THE FALSE POSITIVES ARE UNLIKELY TO CAUSE ADVERSE TRANSIENT OR SEVERE ADVERSE EVENTS. AN INVESTIGATION INTO THE COMPLAINT LOTS K22262 AND K12324 DID NOT REVEAL ANY ISSUES.

    Additional Manufacturer Narrative · 0

    THE BENCHMARK ULTRA STAINER MODULE SERIAL NUMBER WAS (B)(6) . LOT K15868 EXPIRATION DATE: 14 AUG 2024 LOT K12324 EXPIRATION DATE: 15 JUN 2024 LOT K22262 EXPIRATION DATE: 20 NOV 2024 INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED DISCREPANT RESULTS WITH AN UNKNOWN NUMBER OF SAMPLES USING THE CINTEC PLUS CYTOLOGY PMA ASSAY. THE ALLEGED SAMPLES INITIALLY GENERATED POSITIVE STAINING. UPON RESTAINING, NEGATIVE RESULTS WERE OBTAINED WHICH WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48406 CINTEC PLUS CYTOLOGY IMMUNOCYTOCHEMISTRY ASSAY, P16/KI-67 QKF VENTANA MEDICAL SYSTEMS INC. K15868, K12324, K22262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown