BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALK

    MDR report key: 7303925 · Received February 28, 2018

    Report

    Report Number
    2028492-2018-00005
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    February 28, 2018
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    PKW
    PMA / PMN Number
    P140025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THERE WAS A DETERIORATION IN PATIENT HEALTH. WE HAVE ASKED THE CUSTOMER MULTIPLE TIMES WITH NO RESPONSE. THERE IS NO INDICATION OF A MALFUNCTION WITH A VENTANA MEDICAL SYSTEMS INSTRUMENT OR ASSAY. THE ALK PACKAGE INSERT 790-4796 (B)(4) AND INTERPRETATION GUIDE 790-4796 (B)(4) MANDATE THE USE OF SYSTEM CONTROLS RUN WITH ALL PATIENT SAMPLES. THE PACKAGE INSERT SPECIFICALLY CALLS OUT EXCESSIVE NON-SPECIFIC BACKGROUND STAINING OF GLANDULAR EPITHELIAL CELLS, MUSCLE, OR LYMPHOID TISSUE THAT INTERFERES WITH SCORING AS UNACCEPTABLE AND INSTRUCTS USERS THAT IF THE POSITIVE OR NEGATIVE TISSUE CONTROLS FAIL TO DEMONSTRATE APPROPRIATE STAINING OR DEMONSTRATE A CHANGE IN CLINICAL DIAGNOSTIC INTERPRETATION, ANY RESULTS WITH THE TEST SPECIMENS SHOULD BE CONSIDERED INVALID. IN ADDITION, THE ALK INTERPRETATION GUIDE PROVIDES IMAGE EXAMPLES OF UNACCEPTABLE BACKGROUND STAINING. USE OF TISSUE CONTROLS IS ALSO MANDATED BY GLOBAL QUALITY ASSURANCE ORGANIZATIONS AND QUALITY CONTROL GUIDELINES INCLUDING THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS CLIA REGULATIONS. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    THE ALK THERAPY TREATMENT RESULTED IN PATIENT ADMISSION TO INTENSIVE CARE UNIT. ADDITIONAL TESTING WAS CONDUCTED AT SECOND HOSPITAL FOR EGFR AND ALK. THERE WAS HIGH BACK GROUND STAINING OBSERVED HOWEVER THE DOCTOR AT THE SECOND HOSPITAL WAS ABLE TO READ THE SLIDE AND MAKE THE CORRECT NEGATIVE DIAGNOSIS WHICH WAS CONFIRMED WITH FISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145645 ALK PKW VENTANA MEDICAL SYSTEMS INC 06679072001 Y13568

    Patients

    Seq Age Sex Outcome Treatment
    1