BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWABZYMES - OXIDASE

    MDR report key: 322857 · Received March 22, 2001

    Report

    Report Number
    2917572-2001-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2001
    Date of Event
    March 14, 2001
    Report Date
    March 19, 2001
    Manufacturer
    E-Y LABORATORIES, (HK) LTD.
    Product Code
    JTO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE RESULT WITH CONTROL QC STRAIN 25922 AND INCREASED FALSE POSITIVE WITH E.COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12677 SWABZYMES - OXIDASE IN VITRO DIAGNOSTIC JTO E-Y LABORATORIES, (HK) LTD. NA 171103 AND 180629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other