BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 11124237 · Received January 6, 2021

    Report

    Report Number
    3003423869-2021-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 6, 2021
    Manufacturer
    AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
    Product Code
    KPA
    UDI-DI
    05700572035497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ALTERATION OF STAINING IN THIS CASE WAS DUE TO IMPROPER OPERATION OF THE LIQUID SENSOR BOARD. THE PROBLEM WAS SOLVED BY FIELD SERVICE ENGINEER WITH REPLACEMENT OF THE PART. FOLLOWING THE REPLACEMENT, THE INSTRUMENT WAS FULLY OPERATIONAL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND AVAILABLE FOR THE USER. FAILURE MODE DESCRIPTION: FAILURE OF THE LSB, MAY RESULT IN A POTENTIAL FALSE NEGATIVE RESULT IF ASPIRATION POSITION IS INTERMITTENTLY TOO HIGH OR UNEVEN STAINING OCCURS. THIS FAILURE COULD BE DUE TO THE VERTICAL PROBE ASPIRATION POSITION BEING SET ABOVE LIQUID LEVEL OR NOT SUFFICIENTLY DEEP INTO LIQUID, INSUFFICIENT OR NO LIQUID ASPIRATED, INSUFFICIENT OR NO LIQUID DISPENSED, BROKEN LSB, OR LIQUID SENSING SYSTEM OUT OF CALIBRATION. THE LSB FAILURE MODES DESCRIBED ABOVE HAS THE POTENTIAL TO ALTER STAINING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: UNEVEN STAINING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22622 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 KPA AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AS480 05700572035497

    Patients

    Seq Age Sex Outcome Treatment
    1