BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVI® COLOR V2

    MDR report key: 6170476 · Received December 13, 2016

    Report

    Report Number
    3002769706-2016-00510
    Event Type
    Injury
    Date Received
    December 13, 2016
    Report Date
    March 3, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    KPA
    PMA / PMN Number
    C1, EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX THAT A TECHNICIAN WAS MADE ILL BY FUMES FROM THE PREVI® COLOR GRAM (INHALATION OF METHANOL FUMES BY THE USER DURING PREVI® COLOR GRAM USE (S/N 414292130367). BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ALCOHOL USED BY THE CUSTOMER WAS "REAGENT GRADE METHANOL" FROM ELITECH GROUP AND THEIR REFERENCE CODE IS "SS-MEOH". THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS. THE STAINING USES A COMBINATION OF FIVE (5) REAGENTS: A - FUCHSIN OR SAFRANIN (WITH OR WITHOUT ACETONE), B - IODINE, C - CRYSTAL VIOLET, D - DISTILLED WATER, E - ETHANOL, METHANOL, OR REAGENT ALCOHOL. NOTE : A, B AND C REAGENTS ARE PROVIDED BY BIOMÉRIEUX; D AND E REAGENTS ARE NOT SUPPLIED BY BIOMÉRIEUX. THE USER CHOSE METHANOL AS THE TYPE OF ALCOHOL FOR FIXATION AND CLEANING STEPS OF THE STAINING. IF THE CUSTOMER USES METHANOL, THE PREVI® COLOR GRAM MUST BE PLACED IN A CHEMICAL SAFETY HOOD AS INDICATED IN THE USER MANUAL. EXTRACT OF USER MANUAL REF. 514726-1EN1, PART 1-2, PAGE 9/93, TWO WARNINGS: "- THE PREVI® COLOR GRAM MUST BE INSTALLED IN A WELL-VENTILATED AREA. IF VENTILATION IS INADEQUATE, THE INSTRUMENT MUST BE PLACED UNDER A SAFETY HOOD. ALWAYS OPERATE THE INSTRUMENT UNDER A SAFETY HOOD WHEN METHANOL IS IN USE. - IT IS RECOMMENDED THAT YOU USE DISTILLED WATER FOR REAGENT D AND APPROVED ALCOHOL FOR REAGENT E. METHANOL CAN ALSO BE USED FOR REAGENT E, BUT ITS USE IS SUBJECT TO SPECIFIC SAFETY PRECAUTIONS AND REQUIRES THE INSTRUMENT TO BE PLACED UNDER A SAFETY HOOD". THE INVESTIGATION CONCLUDED THE CUSTOMER USED THE PREVI® COLOR GRAM IN AN OFF-LABEL MANNER. THE INSTRUCTIONS FOR USE ARE CLEAR REGARDING THE USE OF METHANOL AS A REAGENT. THE PREVI® COLOR GRAM IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN ISSUE ASSOCIATED WITH THE PREVI® COLOR V2. THE CUSTOMER REPORTED THAT AN EMPLOYEE FILED A WORKERS COMPENSATION CLAIM INDICATING THAT SHE BECAME ILL DUE TO FUMES FROM THE PREVI® COLOR V2 CITING THE PREVI® COLOR V2 AS NOT BEING UNDER A SAFETY HOOD. THE CUSTOMER INDICATED USING "REAGENT GRADE METHANOL" FROM ELITECH GROUP (REFERENCE SS-MEOH) THAT COMES IN A BOTTLE SIMILAR TO THE PREVI® STAIN CONTAINERS, WHICH IS DECANTED INTO AN ACTUAL PREVI® BOTTLE BEFORE ATTACHING TO THE STAINER ITSELF. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EMPLOYEE'S ILLNESS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821456 PREVI® COLOR V2 PREVI® COLOR V2 KPA BIOMERIEUX SA 414292R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention