BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOXOPLASMA 1GM

    MDR report key: 370285 · Received January 2, 2002

    Report

    Report Number
    1938173-2001-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    December 26, 2001
    Report Date
    December 28, 2001
    Manufacturer
    SIGMA DIAGNOSTICS
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORT OF A HIGH NUMBER OF FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOXOPLASMA 1GM QUALITATIVE EIA, INDIRECT LGD SIGMA DIAGNOSTICS * 101K6472

    Patients

    Seq Age Sex Outcome Treatment
    1 *