BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE

    MDR report key: 787477 · Received November 15, 2006

    Report

    Report Number
    787477
    Event Type
    Malfunction
    Date Received
    November 15, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 15, 2006
    Manufacturer
    IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT TAKES AN EXTRA 1-2 DAYS FOR THE ORGANISMS TO GROW OUT, SINCE THE UNLYSED (WHOLE BLOOD) SPECIMEN JUST SITS ON TOP OF THE CHOCOLATE AGAR MEDIA PLATE. NORMALLY THE LYSED BLOOD CELLS ABSORB INTO THE MEDIA. MICROBIOLOGY SUPERVISOR SUSPECTS THE LYSING AGENT IN THE TUBES IS INACTIVE OR CORRUPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE TUBE, BLOOD CULTURE JSC IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS * 609215
    2 ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE TUBE, BLOOD CULTURE JSC IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS * 609111

    Patients

    Seq Age Sex Outcome Treatment
    1 *