BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSLIDE MGS-80 AUTOMATED GRAM STAINER

    MDR report key: 5681325 · Received May 26, 2016

    Report

    Report Number
    5681325
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 23, 2016
    Manufacturer
    QUICKSLIDE, A DIVISION OF HARDY DIAGNOSTICS
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MGS-80 GRAM STAINER SHOWING POTENTIAL CARRYOVER/CROSS CONTAMINATION ISSUE. THE INSTRUMENT HAS BEEN PLACED OUT OF SERVICE; INVESTIGATION INTO GRAM STAIN AND CULTURE RESULTS IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338511 QUICKSLIDE MGS-80 AUTOMATED GRAM STAINER SLIDE STAINER, AUTOMATED KPA QUICKSLIDE, A DIVISION OF HARDY DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1