BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOGICAL INDICATOR SYSTEM

    MDR report key: 4295026 · Received November 24, 2014

    Report

    Report Number
    MW5039316
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 15, 2014
    Report Date
    November 24, 2014
    Manufacturer
    3M
    Product Code
    FRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIO TEST ALARMED JUST SHY OF 3 HOUR TEST TIME INDICATING CULTURE GREW OR POSITIVE FAILURE TO STERILIZE. HOWEVER, THE NEXT DAY IT WAS DISCOVERED IT TESTED NEGATIVE. ORIGINAL TEST WAS FALSE POSITIVE. PT RECEIVED UNNECESSARY DOSE OF ANTIBIOTIC WITH ANTICIPATING EXPOSURE OF UNSTERILE EQUIPMENT BASED ON FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762248 BIOLOGICAL INDICATOR SYSTEM FRC 3M 290

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR