BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCYE SELECTIVE WITH PAV

    MDR report key: 753196 · Received June 22, 2005

    Report

    Report Number
    MW1035867
    Event Type
    Malfunction
    Date Received
    June 22, 2005
    Report Date
    June 22, 2005
    Manufacturer
    HARDY DIAGNOSTICS
    Product Code
    JSJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEGIONELLA MEDIUM BCYE + PAV, LOT 05112 DOES NOT SUPPORT THE GROWTH OF L. PNEUMOPHILA. MFR WAS NOTIFIED IN MAY, BUT HAS SENT THE SAME LOT AS REPLACEMENT THREE TIMES, THE LAST TIME TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCYE SELECTIVE WITH PAV BACTERIOLOGIC MEDIUM JSJ HARDY DIAGNOSTICS * 05112

    Patients

    Seq Age Sex Outcome Treatment
    1 *