BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX PMIC-108 PANEL

    MDR report key: 2826400 · Received November 2, 2012

    Report

    Report Number
    1119779-2012-00021
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    LON
    PMA / PMN Number
    K053241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED TWO ISOLATES TO BD FOR TESTING QUALITY TESTED CUSTOMER RETURNED (B)(6) IN RETENTION LOT #2123271 AND IN A CONTROL PMIC/ID - 108 PANEL. ISOLATE (B)(4) GOT A CEFOXITIN (FOX) MIC OF <=4 AND OXACILLIN (OX) MIC OF 1 IN BOTH THE RETENTION AND THE CONTROL PANEL. FOX SBM (STANDARD BROTH METHOD) MIC SHOWED VERY WEAK GROWTH IN THE MIC 8 WELL WHICH IS "R". OX SBM MIC WAS 0.5 "S". FOR (B)(4), FOX DD (DISC DIFFUSION) WAS 14.38MM AND OX DD WAS 7.83MM. RESULTS CONFIRM THE FALSE SUSCEPTIBLE RESULT FOR FOX. ISOLATE (B)(4) GOT FOX MIC OF 8 "R" AND OX >2 "R" IN BOTH THE TEST AND CONTROL LOT. FOX SBM WAS 8 AND OX SBM WAS 4. (B)(4) IDENTIFIED CORRECTLY AS (B)(6). FOR (B)(4), FOX DD WAS 11.58MM AND OX DD=NO ZONE OF INHIBITION. QC TESTED IN-HOUSE STRAIN (B)(6) IN RETENTION LOT # 2123271 WHICH IDENTIFIED CORRECTLY AS (B)(6). THE BATCH HISTORY RECORD WAS REVIEWED AND FOUND TO BE SATISFACTORY. IT APPEARS THAT THE CUSTOMER'S (B)(6) STRAIN IS ATYPICAL. A CAPA HAS BEEN OPENED TO INVESTIGATE AND ADDRESS THIS TYPE OF SCENARIO. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED ABOUT GETTING A FALSE (B)(6) REPORTED FROM THE PHOENIX SYSTEM WITH A S. AUREUS ISOLATED FROM BLOOD CULTURES. THE PT HAD A HISTORY OF (B)(6) AND THIS CAUSED THE TREATING PHYSICIAN TO QUESTION THE NEWLY OBTAINED RESULTS. THE CUSTOMER REALIZED THAT THE CULTURE ACTUALLY HAD TWO MORPHOLOGY TYPES PRESENT. ONCE THE TWO TYPES WERE ISOLATED, THEY WERE RETESTED BY BOTH PHOENIX AND (B)(6) AND WERE ALSO PLATED TO CHROMAGAR (B)(6). THE PHOENIX INSTRUMENT DETERMINED ONE OF THE ISOLATES TO BE (B)(6), BUT NOT THE OTHER. (B)(6) DETERMINED THAT BOTH ISOLATES WERE RESISTANT TO CEFOXITIN (FOX) WITH ZONES MEASURING 13MM AND 15MM. BOTH ISOLATES DID PRESENT WITH 2 DISTINCTLY DIFFERENT MORPHOLOGIES FROM THE CHROMAGAR. THE TREATING PHYSICIAN HAD CONTINUED THE COURSE OF THERAPY TO COVER FOR THE (B)(6) INFECTION AND PT WAS NOT IMPACTED. THE CUSTOMER SUBMITTED BOTH MORPHOLOGY TYPES TO BD FOR FURTHER F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX PMIC-108 PANEL LON BD DIAGNOSTIC SYSTEMS 2123271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other