BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)

    MDR report key: 8809480 · Received July 19, 2019

    Report

    Report Number
    3006028115-2019-00001
    Event Type
    Death
    Date Received
    July 19, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 19, 2019
    Manufacturer
    NANOSPHERE, INC.
    Product Code
    PEN
    UDI-DI
    00857573006140
    PMA / PMN Number
    K132843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OR ALLEGATION FROM THE FIELD/CLINIC THAT THE DEVICE CONTRIBUTED TO THE INCIDENT. LUMINEX'S INVESTIGATION HAS DETERMINED THAT THIS IS NOT A DEVICE MALFUNCTION. THE PRODUCT IS ADEQUATELY LABELED AND THE PRODUCT PERFORMED ACCORDING TO PRODUCT CLAIMS. LUMINEX HAS MADE MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE MEDICAL DIRECTOR WITH REGARDS TO THIS CASE, BUT HAS NOT RECEIVED ANY MORE INFORMATION. LUMINEX'S INVESTIGATION WAS NOT ABLE TO DETERMINE ROOT CAUSE AS THE PATIENT SAMPLE WAS DISCARDED AND NOT AVAILABLE FOR INTERNAL TESTING. INSTRUMENT AND CONSUMABLE DATA WAS REVIEWED AND DOCUMENTATION SHOWED NO INDICATION OF DEVICE OR CONSUMABLE MALFUNCTION. THE PACKAGE INSERT LABELING CLEARLY STATES IN RARE INSTANCES FOR SPECIMENS WITH ORGANISMS CARRYING A RESISTANCE MARKER, BC-GN MAY NOT YIELD A POSITIVE RESULT FOR THE RESISTANCE MARKER WHEN THE ORGANISM(S) IS DETECTED. THE PACKAGE INSERT LABELING STATES: BC-GN IS INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL BLOODSTREAM INFECTIONS; HOWEVER, IS NOT USED TO MONITOR THESE INFECTIONS. THE PACKAGE INSERT LABELING STATES: A NOT DETECTED RESULT FOR ANY OF THE ANTIMICROBIAL RESISTANCE MARKERS DOES NOT INDICATE SUSCEPTIBILITY, AS RESISTANCE MAY OCCUR BY OTHER MECHANISMS. SUB-CULTURING AND AST TESTING IS REQUIRED IN ORDER TO ASSIGN A RESISTANT AND/OR SUSCEPTIBLE PHENOTYPE TO EACH ISOLATE RECOVERED FROM THE BLOOD CULTURE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2019 SAMPLE (B)(6) WAS PROCESSED USING THE CARTRIDGE ID (B)(6) VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) ON THE VERIGENE SYSTEM. VERIGENE RESULT WAS PSEUDOMONAS AERUGINOSA DETECTED AND REPORTED OUT TO A PHYSICIAN ON (B)(6) 2019. PATIENT SAMPLE WAS RUN ON VITEK, AND THE VITEK RESULT WAS REPORTED ON (B)(6) 2019 AS P.AERUGINOSA IDENTIFIED, CEFAZOLIN AND MEROPENEM RESISTANT. THE HOSPITAL FACILITY NOTIFIED LUMINEX (NANOSPHERE) OF THE DISCREPANCY BETWEEN THE BC-GN AND VITEK RESULTS ON (B)(6) 2019 AND PROVIDED DETAILS OF THE TREATMENT. THE PATIENT WAS TREATED WITH MEROPENEM AND TOBRAMYCIN FOR 48 HOURS FOLLOWING THE VERIGENE RESULT. FOLLOWING THE VITEK RESULT, TREATMENT WAS ALTERED AND MEROPENEM WAS DISCONTINUED ON (B)(6) 2019. CIPROFLOXACIN AND AVYCAZ WERE ADDED TO TREATMENT ON (B)(6 2019. ON (B)(6) 2019, THE PATIENT EXPIRED FROM CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600300 VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) GRAM-NEGATIVE BLOOD CULTURE TEST PEN NANOSPHERE, INC. 20-006-021 031519021B 00857573006140

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death