BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX PMIC/ID-62 PANEL

    MDR report key: 2471996 · Received February 23, 2012

    Report

    Report Number
    1119779-2012-00001
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    LON
    PMA / PMN Number
    K031679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY IS CURRENTLY IN THE PROCESS OF COMPLETING THIS INVESTIGATION. THE CUSTOMER'S ISOLATE WAS RECEIVED ON (B)(4) 2012. THE ISOLATE WILL BE USED IN TESTING WITH RETENTION SAMPLE. UPON RECEIPT OF THE RETURN, THE ISOLATE WAS SUBCULTURED AND IT WAS DETERMINED THAT THERE WERE TWO DIFFERENT COLONIAL MORPHOLOGIES THAT MUST BE SEPARATED IN ORDER FOR TESTING TO OCCUR. A SUPPLEMENTAL REPORT WILL BE FILED UPON INVESTIGATION COMPLETION AND ANALYSIS OF THE DATA.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT ABOUT GETTING A "FALSE-SUSCEPTIBLE" RESULT FOR HIGH-LEVEL GENTAMICIN (>500 UG/ML) WITH ENTEROCOCCUS FAECALIS IN THE PHOENIX SYSTEM. THE ORGANISM WAS ISOLATED FROM BLOOD CULTURE. THE PT WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THE ORGANISM WAS AGAIN ISOLATED, AND TESTING IN A COMPETITOR SYSTEM SHOWED IT TO BE RESISTANT TO HIGH LEVEL GENTAMICIN. THE ISOLATE WAS AGAIN TESTED BY THIS LAB IN THE PHOENIX SYSTEM AND AGAIN GAVE SUSCEPTIBLE RESULTS. THE ISOLATE WAS THEN TESTED IN DUPLICATE IN ANOTHER PANEL LOT, AND GAVE ONE RESISTANT AND ONE SUSCEPTIBLE RESULT. CONCURRENTLY, THE ISOLATE WAS TESTED BY DISC DIFFUSION AND SHOWED A ZONE OF '0', INDICATING A VERY RESISTANT ORGANISM. THE PT WAS TREATED WITH A COMBINATION OF GENTAMICIN AND A BETA-LACTAM DRUG, BASED ON THE PHOENIX RESULTS. THE PT FAILED TO RESPOND TO TREATMENT AND WAS SUBSEQUENTLY DIAGNOSED WITH ENDOCARDITIS AND HAD SURGERY FOR FAILURE OF MEDICAL TREATMENT. A CULTURE WAS TAKEN AT THE TIME OF SURGERY AND FOUND TO BE RESISTANT TO HIGH LEVEL GENTAMICIN WHEN TESTED AT ANOTHER LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX PMIC/ID-62 PANEL LON BD DIAGNOSTIC SYSTEMS 1278245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention