BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM

    MDR report key: 338408 · Received June 12, 2001

    Report

    Report Number
    MW1022192
    Event Type
    Malfunction
    Date Received
    June 12, 2001
    Date of Event
    January 16, 2001
    Report Date
    June 12, 2001
    Manufacturer
    DIESSE DIAGNOSTICA SENESE SRI
    Product Code
    GKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 1/01, MEDICAL CENTER STARTED UTILIZINGB A NEW PRODUCT, VACU-TEC TUBE IN THE VES-MATIC ESR TESTING SYSTEM FOR DETERMINING THE SEDIMENTATION RATES IN PT POPULATION. A BLOOD CULTURE DRAWN FROM ONE OF PTS YIELDED OCHROBACTRUM ANTHROPI. IT WAS DETERMINED FROM THE PT'S CLINICAL CONDITION AND WORK-UP THAT THIS ORGANISM WAS MOST LIKELY A CONTAMINANT AND THE PT SUBSEQUENTLY WAS NOT TREATED WITH ANTIMICROBIALS. SINCE THIS FIRST CASE AN ADD'L 12 POSITIVES BLOOD CULTURES HAVE GROWN O. ANTHROPI WITH NO CLINICAL DISEASE IN THE 12 PTS. TWO PTS ALSO GREW S. MALTOPHILIA FROM THE SAME BLOOD CULTURE THAT GREW O. ANTHROPI. CLINICAL REVIEW OF PT MEDICAL RECORDS IS ONGOING. FURTHER INFO WILL FOLLOW WHEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26866 VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM ESR TESTING SYSTEM GKB DIESSE DIAGNOSTICA SENESE SRI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other