BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPAP 300 QC SYSTEM

    MDR report key: 319559 · Received March 8, 2001

    Report

    Report Number
    3026575-2001-00001
    Event Type
    Injury
    Date Received
    March 8, 2001
    Report Date
    March 1, 2001
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON 02/07/01, TRIPATH IMAGING, INC. WS SERVICED WITH A LEGAL COMPLAINT ALLEGING MEDICAL MALPRACTICE BY PLAINTIFF'S PHYSICIAN, A CLINICAL LABORATORY, AND ADDITIONAL BUT UNNAMED DEFENDENTS. THE TRIPATH WAS NAMED AS ONE OF THOSE DEFENDANTS THROUGH SERVICE OF THE COMPLAINT AND AMENDMENT TO THE COMPLAINT. INFORMATION RECEIVED IN THE FORM OF THIS LEGAL COMPLAINT ALLEGES THAT THE CLINICAL LABORATORY REPORTED A "FALSE NEGATIVE" ANALYSIS OF A PAP SMEAR IN 1998. THE COMPLAINT FURTHER ALLEGES THAT THE PLAINTIFF "HAS SUFFERED SERIOUS INJURIES" INCLUDING "DELAYED DIAGNOSIS OF HIGH GRADE METAPLASTIC DYSPLASIA" AND METASTATIC, INVASIVE SQUAMOUS CARCINOMA." THE LEGAL COMPLAINT DOES NOT IDENTIFY A PARTICULAR TRIPATH DEVICE OR CONTAIN ANY SPECIFIC ALLEGATIONS RELATING TO A TRIPATH DEVICE; RATHER, THE COMPLAINT CONTAINS ONLY A GENERAL ALLEGATION THAT TRIPATH IS AMONG THE PERSONS RESPONSIBLE FOR PLAINTIFF'S INJURIES. BASED ON THE LIMITED INFORMATION PROVIDED, IF ANY TRIPATH DEVICE WAS INVOLVED IN THIS INCIDENT, IT IS BELIEVED TO HAVE BEEN AN AUTOPAP 300 QC SYSTEM, WHICH WAS THE QUALITY CONTROL SYSTEM DEVICE MARKETED AT THE TIME OF THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9936 AUTOPAP 300 QC SYSTEM AUTOMATIC PAP QC SCREENER SYSTEM MKQ TRIPATH IMAGING, INC. AP300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening