BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48 INSTRUMENT SYSTEM

    MDR report key: 10389557 · Received August 11, 2020

    Report

    Report Number
    2022180-2020-00146
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 11, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BASED ON COMPLAINT REPORT AND INVESTIGATED FAILURE MODE, THERE WAS A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING WITH MULTIPLE ANTIBODIES AT RANDOM SLIDE LOCATIONS. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858666 AUTOSTAINER LINK 48 INSTRUMENT SYSTEM AUTOSTAINER LINK 48 INSTRUMENT SYSTEM KPA DAKO NORTH AMERICA, INC AS480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other