BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL SEPTI-CHEK

    MDR report key: 20391 · Received March 17, 1995

    Report

    Report Number
    MW1005493
    Event Type
    Malfunction
    Date Received
    March 17, 1995
    Date of Event
    February 6, 1995
    Report Date
    March 3, 1995
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 8/94, RPTR'S LABORATORY NOTED A CLUSTER OF CANDIDA GUILLERMONDII ISOLATED FROM BLOOD CULTURES. THIS ORAGNISM IS RARELY ISOLATED FROM BLOOD CULTURES. FURTHER, THE ORGANISM WAS NEVER ISOLATED FROM MORE THAN ONE BLOOD CULTURE BOTTLE AND THE PTS FROM WHOM THE ORGANISM WAS ISOLATED DID NOT HAVE A CLINICAL PICTURE OF FUNGAL SEPSIS OR RISK FOR FUNGAL DISEASE. IN OTHER WORDS, THESE ISOLATES SEEMED TO BE CONTAMINANTS. RPTR CONTACTED MFR TO ALERT THEM OF THIS CONCERN THAT THEY HAD A LOW LEVEL CONTAMINATION OF THEIR AEROBIC BLOOD CULTURE SYSTEM (BOTTLES OR SLIDE CHAMBERS). AT THE TIME, RPTR WAS ASSURED THAT THERE HAD BEEN NO OTHER COMPLAINTS. HOWEVER, IN 11/94, RPTR RECEIVED AN "IMPORTANT PRODUCT NOTICE" REGARDING SPORADIC RPTR CONTAMINATION OF THEIR SUBCULTURE SLIDES. UNFORTUNATELY, IN SPITE OF MFR'S ASSURANCES TO THE CONTRARY, IT APPEARS THAT THEY HAVE NOT FIXED THE PROBLEM. EARLIER THIS MONTH, RPTR ENCOUNTERED A CANDIDA GUILLERMONDII ISOLATE FROM A SINGLE AEROBIC BOTTLE THAT WAS MORPHOLOGICALLY AND BIOCHEMICALLY IDENTICAL TO THOSE ENCOUNTERED LAST SUMMER. THE ISOLATE WAS CONSIDERED A CONTAMINANT BY THE PT'S PRIVATE INTERNIST AS THE PT HAD NO RISK FACTORS FOR FUNGAL INFECTION AND DID NOT HAVE A CLINICAL COURSE COMPATIBLE WITH SYSTEMIC FUNGAL INFECTION. RPTR HAS AGAIN CONTACTED THE MFR WITH HIS CONCERNS ABOUT CONTINUING CONTAMINATION OF THEIR PRODUCT. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL SEPTI-CHEK MICROBIOLOGIC CULTURE MEDIA (DIAGNOSIS) JSJ BECTON DICKINSON MICROBIOLOGY SYSTEMS 0518K41KB

    Patients

    Seq Age Sex Outcome Treatment
    1 *