BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK MS - DS SLIDE

    MDR report key: 4987902 · Received August 10, 2015

    Report

    Report Number
    3002769706-2015-00067
    Event Type
    Injury
    Date Received
    August 10, 2015
    Report Date
    July 17, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    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 1¿L 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. 4501- 2233." "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.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED ACCIDENTAL PREPARATION AND TESTING OF A NON-DEACTIVATED BRUCELLA ORGANISM USING THE VITEK MS IDENTIFICATION SYSTEM AND ASSOCIATED DISPOSABLE TEST SLIDE (REF. (B)(4), LOT NUMBER UNKNOWN). THE CUSTOMER RECEIVED A SAMPLE THAT WAS RULED OUT AS BRUCELLA BECAUSE IT WAS DETERMINED TO BE OXIDASE NEGATIVE ON TWO SEPARATE ISOLATES AT 48 HOURS. THE LABORATORY PROCESSED THE SAMPLE VIA VITEK MS AND OBTAINED AN IDENTIFICATION (ID) OF ACIBACTRUM. THE FOLLOWING DAY ANOTHER ISOLATE FROM THE SAME PATIENT WAS PROCESSED AND FOUND TO BE OXIDASE POSITIVE. THE LABORATORY SENT THE SAMPLE TO PUBLIC HEALTH FOR CONFIRMATION TESTING, AND IT WAS FOUND TO BE BRUCELLA. INITIAL ISOLATES WERE RETESTED, AND RETURNED AN OXIDASE RESULT OF POSITIVE. THE LABORATORY FOLLOWED THE CDC PROTOCOL FOR REMOVAL. THESE ISOLATES WERE NOT PREPARED UNDER A HOOD. THE EXPOSED LABORATORY PERSONNEL ARE CONSIDERED LOW RISK BY OCCUPATIONAL HEALTH, WERE PRESCRIBED PROPHYLAXIS ANTIBIOTICS, AND WILL BE MONITORED BY THEIR OCCUPATIONAL HEALTH FOR THE NEXT YEAR. 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. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521441 VITEK MS - DS SLIDE VITEK MS SLIDE PEX BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention