BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEGATIVE MIC 38

    MDR report key: 4260709 · Received November 14, 2014

    Report

    Report Number
    2919016-2014-00043
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPARE RESULTS FROM EXPECTED SURVEY RESULTS.

    Description of Event or Problem · 1

    (B)(6) SURVEY RESULT REPORTED FALSE SUSCEPTIBLE FOR CFZ ON ESBL USING SIEMENS NEG MIC 38 PANEL. TEST RESULTS YIELDED E. COLI FALSE SUSCEPTIBLE CEFAZOLIN (CFZ) RESULTS. PROFICIENCY ISOLATE'S EXPECTED RESULTS WERE RESISTANT TO CEFAZOLIN (CFZ). CUSTOMER IS A MANUAL READ USER. THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY ISOLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738802 NEGATIVE MIC 38 NEGATIVE MIC 38 JWY SIEMENS HEALTHCARE DIAGNOSTICS INC. B1017-412 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1