BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOXOPLASMA 1GM

    MDR report key: 356272 · Received October 9, 2001

    Report

    Report Number
    1938173-2001-00001
    Event Type
    Malfunction
    Date Received
    October 9, 2001
    Date of Event
    September 21, 2001
    Report Date
    October 8, 2001
    Manufacturer
    SIGMA DIAGNOSTICS
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTS OF A HIGH NUMBER OF FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45612 TOXOPLASMA 1GM QUALITATIVE EIA, INDIRECT LGD SIGMA DIAGNOSTICS * 021K6481

    Patients

    Seq Age Sex Outcome Treatment
    1 *