BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT ALERT BLOOD CULTURE BOTTLE

    MDR report key: 29260 · Received January 5, 1996

    Report

    Report Number
    MW1008069
    Event Type
    Malfunction
    Date Received
    January 5, 1996
    Date of Event
    January 3, 1996
    Report Date
    January 3, 1996
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB BLOOD CULTURE MEDIUM CONTAINED GRAM-POSITIVE BACTERIA THAT WERE NOT VIABLE, BUT LED RPTR TO CONCLUDE THAT THEY WERE IN THE CULTURE OF THE PT'S SPECIMEN. ONLY ONE LOT OF MEDIA WAS AFFECTED. 10 BOTTLES WHICH WERE KNOWN TO BE NEGATIVE FOR GROWTH OF ORGANISMS WERE GRAM STAINED AND FOUND TO CONTAIN GRAM-POSITIVE COCCI. TEN BOTTLES FROM A DIFFERENT LOT NUMBER WERE FOUND TO BE NEGATIVE BY GRAM STAIN. FOR TWO PTS, POSITIVE REPORTS WERE GIVEN TO THE PHYSICIANS. UNTIL THE PROBLEM WAS RESOLVED THOSE REPORTS REMAINED IN THE PT'S CHART. IN ONE CASE, THE REPORT WAS IN THE COMPUTER FOR 2 WEEKS; IN THE OTHER, FOR 4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT ALERT BLOOD CULTURE BOTTLE CULTURE MEDIUM JSC ORGANON TEKNIKA CORP. 203314

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other