BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAM NEGATIVE PANEL

    MDR report key: 3186990 · Received June 20, 2013

    Report

    Report Number
    2919016-2013-00003
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    July 1, 2011
    Report Date
    May 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LRG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE NOT EVALUATED - THIS WAS REPORTED IN AN ARTICLE. RESULTS: ISOLATE NOT AVAILABLE FOR EVALUATION. CONCLUSIONS: ISOLATE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    AN ARTICLE IN THE JOURNAL OF MEDICAL MICROBIOLOGY (2013), 62 STATES A MICROSCAN PANEL (PANEL TYPE AND LOT NUMBER UNKNOWN) MISIDENTIFIED K. VARIICOLA AS K. PNEUMONIAE. THE ISOLATE WAS CULTURED FROM PATIENT BLOOD SAMPLE AND IDENTIFIED AS K. PNEUMONIAE, 16S RDNA PCR TESTING IDENTIFIED THE ISOLATE AS K. VARIICOLA AS DID GENETIC ANALYSIS. THE ARTICLE NOTED THAT THE INCORRECT IDENTIFICATION OF K. PNEUMONIAE LIKELY WOULD HAVE BEEN SEEN WITH ANY OF THE AUTOMATED SYSTEMS, DUE TO THE VERY RARE ISOLATION OF K. VARIICOLA. IN ADDITIONAL, VIRULENCE OF K. VARIICOLA IS NOT CLEAR AND SEVERE INFECTION HAS NOT BEEN DESCRIBED. THE MIC'S WERE REPORTED CORRECTLY BUT THE PATIENT DIED DESPITE THE IMMEDIATE AND APPROPRIATE ADMINISTRATION OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280993 GRAM NEGATIVE PANEL GRAM NEGATIVE PANEL LRG SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death RADIOTHERAPY| CHEMOTHERAPY