BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSITITRE GRAM NEGATIVE AUTOIDENTIFICATION PLATE (AP80)

    MDR report key: 265712 · Received February 24, 2000

    Report

    Report Number
    8021914-2000-00001
    Event Type
    Death
    Date Received
    February 24, 2000
    Date of Event
    January 25, 2000
    Report Date
    January 27, 2000
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Product Code
    LQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN GREECE. THE FOLLOWING INFO WAS PROVIDED BY A GREEK DISTRIBUTOR: A PT ISOLATE WAS PROCESSED ON A SENSITITRE AP80 AUTOIDENTIFICATION PLATE AND THE RESULT WAS PSEUDOMONAS 83%. IT WAS IDENTIFIED BY PASTEUR LATEX AS A NEISSERIA. THE PT DIED FROM FULMINANT MENINGITS. THE PRODUCT SENSITITRE LITERATURE AND PACKAGE INSERTS DO NOT CLAIM THAT THE SYSTEM CAN IDENTIFY NEISSERIA. THE PACKAGE INSERT STATES THAT THE AP80 PERMITS IDENTIFICATION OF THOSE AS LISTED IN THE PACKAGE INSERT; NEISSERIA IS NOT LISTED. IT ALSO STATES THAT FINAL IDENTIFICATION MUST BE LEFT TO THE DISCRETION OF THE MICROBIOLOGIST AND THAT OTHER TESTS MAY BE TAKEN INTO CONSIDERATION, INCLUDING THE SOURCE OF THE SPECIMEN, THE PT'S HISTORY, COLONIAL MORPHOLOGY, AND MICROSCOPIC APPEARANCE. AND IT FURTHER STATES THAT THE AP80 IS DESIGNED SPECIFICALLY FOR THE IDENTIFICATION OF GRAM NEGATIVE BACTERIA LISTED IN THE INSERT AND REACTIONS PRODUCED BY MEMBERS OF OTHER BACTERIAL SPECIES WILL NOT YIELD A CORRECT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSITITRE GRAM NEGATIVE AUTOIDENTIFICATION PLATE (AP80) IN VITRO DIAGNOSTIC LQM TREK DIAGNOSTIC SYSTEMS, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death