BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLY

    MDR report key: 2935515 · Received November 27, 2012

    Report

    Report Number
    2935515
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 26, 2012
    Manufacturer
    3M HEALTHCARE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TEST STRIPS FAILED TO PASS DURING QUALITY ASSURANCE TEST ON DAY 3 OR 6 CYCLES IN OER (OLYMPUS ENDOSCOPIC REPROCESSOR). THE ALDAHOL WAS DUMPED AND FRESH ALDAHOL WAS PLACED IN OER. A DIFFERENT LOT # OF STRIPS WAS USED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLY SEMI-QUANTITATIVE CHEMICAL INDICATOR FLE 3M HEALTHCARE * 2014-09AE

    Patients

    Seq Age Sex Outcome Treatment
    1 *