BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL

    MDR report key: 7388098 · Received March 30, 2018

    Report

    Report Number
    MW5076254
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 27, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BIOMERIEUX / BIOFIRE
    Product Code
    JJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FILM ARRAY BIOFIRE GASTROINTESTINAL PANEL DETECTING POSSIBLE CONTAMINATION (DNA - NON VIABLE) WITH VIBRO CHOLERA. LOT NUMBER 648217 ((B)(6) 2017) AND LOT NUMBER 800818 ((B)(6) 2018). FILM ARRAY BIO FIRE BLOOD CULTURE IDENTIFICATION PANEL (BCID) LOT 822618 ((B)(6) 2018) PROTEUS SPECIES. BIOFIRE COMMUNICATION FSCA NUMBER (B)(4) DATED (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227685 BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL GASTROINTESTINAL PATHOGEN PANEL JJH BIOMERIEUX / BIOFIRE 2FA9F48F 648217
    227686 BIOFIRE FILM ARRAY GASTROINTESTINAL GI PANEL GASTROINTESTINAL PATHOGEN PANEL JJH BIOMERIEUX / BIOFIRE 2FA90840 800818
    227687 BIOFIRE FILM ARRAY BLOOD CULTURE IDENTIFICATION PANEL GRAM NEGATIVE BACTERIA AND RESISTANCE MARKER PEN BIOMERIEUX / BIOFIRE 822618

    Patients

    Seq Age Sex Outcome Treatment
    1