BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK MS DS-SLIDE

    MDR report key: 4987899 · Received August 10, 2015

    Report

    Report Number
    3002769706-2015-00068
    Event Type
    Injury
    Date Received
    August 10, 2015
    Report Date
    July 30, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. VIABILITY STUDIES WERE PERFORMED IN NOVEMBER 2013 AND OCTOBER 2014 FOR BRUCELLA STRAIN AFTER SPOTTING OF CHCA MATRIX ON A VITEK® MS SLIDE. THE CONCLUSION OF THE STUDY WAS THAT A DIRECT DEPOSIT OF 1UL OF CHCA MATRIX IS NOT ENOUGH TO GUARANTEE A TOTAL INACTIVATION OF ALL STRAINS. IN GENERAL, CHCA MATRIX INACTIVATES MOST OF BACTERIA COMMONLY ENCOUNTERED IN LABORATORIES WITH THE CONDITIONS THAT THE CUSTOMER IS CORRECTLY COVERING ALL THE SPOTS WITH MATRIX AND IS NOT IN PRESENCE OF BACILLUS SPORES. THE PACKAGE INSERT OF CHCA MATRIX STATES THE FOLLOWING: - "THE VITEK® MS-CHCA MATRIX IS USED WITH THE VITEK® MS SYSTEM TO ENABLE THE IDENTIFICATION OF MICROORGANISMS. THE MATRIX ABSORBS ENERGY FROM THE VITEK® MS LASER AND TRANSFERS IT TO THE MICROORGANISMS TO ENABLE IONIZATION. THE VITEK® MS-CHCA MATRIX IS USED EXCLUSIVELY WITH THE VITEK® MS INSTRUMENT AS INDICATED IN THE VITEK® MS WORKFLOW USER MANUAL REF. (B)(4)." "ALL SPECIMENS, MICROBIAL CULTURES AND INOCULATED PRODUCTS SHOULD BE CONSIDERED INFECTIOUS AND HANDLED APPROPRIATELY. ASEPTIC TECHNIQUE AND USUAL PRECAUTIONS FOR HANDLING THE BACTERIAL GROUP STUDIED SHOULD BE OBSERVED THROUGHOUT THIS PROCEDURE. REFER TO "CLSI® M29-A, PROTECTION OF LABORATORY WORKERS FROM OCCUPATIONALLY ACQUIRED INFECTIONS; APPROVED GUIDELINE - CURRENT REVISION". FOR ADDITIONAL HANDLING PRECAUTIONS, REFER TO "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES - CDC/NIH - LATEST EDITION", OR TO THE REGULATIONS CURRENTLY IN USE IN EACH COUNTRY." THE PACKAGE INSERT OF VITEK® MS TARGET SLIDE STATES THE SAME WARNING REGARDING INFECTIOUS PRODUCTS. MOREOVER, THE WASTE DISPOSAL SECTION INDICATES: "THE TARGET SLIDES MUST BE DISCARDED AFTER USE ACCORDING TO GOOD LABORATORY PRACTICE." FOLLOWING THE OCCURRENCE OF THE EVENT ASSOCIATED WITH THIS REPORT, R&D TESTS WERE PERFORMED TO IDENTIFY ANY EXTERNAL AND INTERNAL VITEK® MS INSTRUMENT CONTAMINATION. TWO (2) STRAINS WERE TESTED : SALMONELLA TYPHIMURIUM AND BACILLUS LICHENIFORMIS IN ITS SPORULATIVE FORM. VITEK® MS TARGET SLIDES WERE PREPARED WITH AND WITHOUT CHCA MATRIX. > NO INTERNAL OR EXTERNAL CONTAMINATION OF THE INSTRUMENT WAS OBSERVED AFTER THE INTRODUCTION OF THE TWO BACTERIAL STRAINS ON A SLIDE WITH AND WITHOUT MATRIX . > NO COLONY WAS OBSERVED ON ANY OF THE CULTURE MEDIA AFTER 48 HOURS OF INCUBATION. > AFTER 72 HOURS OF INCUBATION, FEW COLONIES COULD BE OBSERVED AND WERE IDENTIFIED AS MICROCOCCUS LUTEUS, STAPHYLOCOCCUS ARLETTAE AND STAPHYLOCOCCUS HOMINIS. THESE THREE SPECIES ARE CONTAMINANT SPECIES FROM THE ENVIRONMENT. > AFTER ONE WEEK OF INCUBATION, TWO MOLDS COULD BE OBSERVED, ALSO SPECIES FROM THE ENVIRONMENT (PENICILLIUM CHRYSOGENUM AND ASPERGILLUS NIGER COMPLEX). BASED ON THE STUDY, THE TESTING OF BRUCELLA STRAINS IS UNLIKELY TO CONTAMINATE THE INSTRUMENT; CONSEQUENTLY THERE IS NO NEED FOR SPECIFIC INSTRUMENT DECONTAMINATION. THE ONLY CONTAMINATED COMPONENT IS THE SLIDE WHICH SHOULD BE REMOVED AS BIOLOGICAL WASTE. THERE IS NO REPORT FROM THE HOSPITAL OR PHYSICIAN INDICATING FURTHER TREATMENT OR ANY ADVERSE IMPACT TO HEALTH FOR THE IMPACTED LABORATORY PERSONNEL. REVIEW OF PRODUCT LABELING INDICATES THE PRECAUTIONS ARE SUFFICIENT FOR THE USE OF THE VITEK® MS-CHCA MATRIX AND THE VITEK® MS SLIDE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) REPORTED ACCIDENTAL TESTING OF A NON-DEACTIVATED BRUCELLA ORGANISM ORGANISM USING THE VITEK MS IDENTIFICATION SYSTEM AND ASSOCIATED DISPOSABLE TEST SLIDE (REF. 410893, LOT NUMBER UNKNOWN). NYDOH IS A REFERENCE LAB; THEY RECEIVED A PATIENT SAMPLE THAT HAD BEEN RULED OUT FOR BRUCELLA BY THE GENERAL LAB. FOLLOWING SAMPLE PREPARATION IN A BSL2+ HOOD WITH GLOVES AND GOWN, THEY PROCESSED THE SAMPLE ON THE VITEK MS AND DID NOT RECEIVE AN IDENTIFICATION (ID) RESULT. AFTER THE SAMPLE WAS RUN, THEY FOUND THAT THERE WAS RESIDUAL BRUCELLA ON THE SLIDE. THEY WERE ABLE TO PERFORM SEVERAL CONFIRMATORY TESTS INCLUDING PCR TO SPECIATE THE ORGANISM AND FOUND BRUCELLA MELENTENSIS. THE EXPOSED PERSONNEL WERE CONSIDERED LOW RISK BY OCCUPATIONAL HEALTH AND ARE BEING MONITORED EVERY SIX WEEKS FOR IGG AND IGM. ORGANISMS SUCH AS BRUCELLA REQUIRE DEACTIVATION PRIOR TO EXPOSURE OUTSIDE OF A HOOD OR OTHER VENTILATED / NEGATIVE PRESSURE ENVIRONMENT. THE METHOD OF DEACTIVATION IS AT THE DISCRETION OF THE FACILITY. REMOVAL FROM THE HOOD PRIOR TO COMPLETE DEACTIVATION CAN RESULT IN EXPOSURE. IN THIS CASE, SAMPLE DEACTIVATION WAS NOT PERFORMED BY THE CUSTOMER AND LABORATORY PERSONNEL WERE POTENTIALLY EXPOSED TO BRUCELLA. THE VITEK MS SYSTEM WAS DECONTAMINATED FOLLOWED BY DECONTAMINATION OF THE ROOM. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521662 VITEK MS DS-SLIDE VITEK MS SLIDE PEX BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention