BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMAX 190 PLUS

    MDR report key: 300544 · Received October 11, 2000

    Report

    Report Number
    1938173-2000-00004
    Event Type
    Malfunction
    Date Received
    October 11, 2000
    Date of Event
    September 11, 2000
    Report Date
    September 11, 2000
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IMPROPER SEQUENCING OCCURRED WHEN ABERRANTLY LOW RESULT ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMAX 190 PLUS COAGULATION ANALYZER SYSTEM JPA SIGMA DIAGNOSTICS, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *