BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) AST-P635 TEST KIT

    MDR report key: 5177562 · Received September 8, 2011

    Report

    Report Number
    1950204-2015-00077
    Event Type
    Death
    Date Received
    September 8, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 9, 2011
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE INVESTIGATION TESTING INCLUDED: ORGANISM IDENTIFICATION TESTING VIA VITEK® 2 GP ID CARD CONFIRMED STAPHYLOCOCCUS AUREUS. VITEK® 2 AST- P635 CARDS (CUSTOMER LOT AND RANDOM LOT) PROVIDED A RESULT OF OXACILLIN MIC =0.5 MG/L (SUSCEPTIBLE) AND OXSF NEGATIVE. THE CUSTOMER RESULT WAS DUPLICATED. AGAR DILUTION (AD), THE REFERENCE METHOD USED FOR OXACILLIN DEVELOPMENT, OBTAINED MIC = 0.5MG/L (SUSCEPTIBLE). ETEST® OXACILLIN PROVIDED A RESULT OF 1 MG/L (SUSCEPTIBLE). PCR MECA OBTAINED POSITIVE RESULT FOR GENE MECA ((B)(6) STRAIN CONFIRMED). CEFOXITIN KIRBY BAUER (KB), THE REFERENCE METHOD USED FOR CEFOXITIN SCREEN TEST ON VITEK® 2 AST CARD, OBTAINED A DIAMETER OF 18MM (RESISTANT). CHROMID TM MRSA SMART AGAR: GROWTH OF PINK COLONIES, CHARACTERISTIC OF (B)(6) STRAIN. THE VITEK® 2 RESULT FOR OXACILLIN MIC IS IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD (AGAR DILUTION) - NO CATEGORY ERROR. VITEK® 2 CEFOXITIN SCREEN TEST IS DISCREPANT AS COMPARED TO DIFFUSION TEST ((B)(6) RESULT ON VITEK® 2 COMPARED TO KIRBY BAUER). THE INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATE IS AN ATYPICAL STRAIN FOR VITEK® 2 SYSTEM PHENOTYPIC AST TESTING METHOD, WHICH IS COLORIMETRIC AND MEASURES ORGANISM GROWTH BEHAVIOR. GENETIC MEASUREMENT TECHNIQUES (PCR) AND NON-AUTOMATED METHODS SUCH AS KIRBY-BAUER DISK DIFFUSION AND CHROMID TM CHROMOGENIC MEDIA ARE MORE CONDUCIVE TO TESTING CERTAIN SLOWER-GROWTH ORGANISMS. THE VITEK® 2 AST- P635 CARD IS PERFORMING IN ACCORDANCE WITH SPECIFICATIONS AND IS IN AGREEMENT WITH THE REFERENCE METHOD (AGAR DILUTION) FOR THE DEVELOPMENT OF OXACILLIN.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) REPORTED A FALSE SUSCEPTIBLE OXACILLIN RESULT (AND NEGATIVE CEFOXITIN SCREEN, (B)(6)) FOR A STAPHYLOCOCCUS PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK 2 AST-P635 TEST KIT. THE PATIENT LATER EXPIRED OF TOXIC SHOCK. DAVID (B)(6) STATED THAT WHEN THE PATIENT ISOLATE WAS FIRST TESTED, THE OXACILLIN MIC=1 (SUSCEPTIBLE), AND THE PHENOTYPE PROPOSED WAS A CHOICE BETWEEN ACQ PASE (ACQUIRED PENICILLINASE) AND MOD-PBP (MECA); THEREFORE THE LABORATORY PERSONNEL WERE ALERTED TO THE POSSIBILITY OF (B)(6), BUT CHOSE TO PERFORM NO CONFIRMATORY/ALTERNATIVE TESTING, AND REPORTED IT AS (B)(6) TO THE TREATING PHYSICIAN. THE PATIENT ISOLATE WAS SENT TO A REFERENCE LAB (B)(6) FOR CONFIRMATORY TESTING. THE RESULT OF PCR TESTING RETURNED AS (B)(6); THEREFORE (B)(6). UPON RECEIPT OF THE (B)(6) RESULT FROM THE REFERENCE LAB, THE CUSTOMER RE-STREAKED THE PATIENT ISOLATE ONTO (B)(4) MEDIA, REPEATED VITEK 2 AST-P635 TESTING, AND OBTAINED AN OXACILLIN MIC OF 0.5. THE CUSTOMER ALSO PERFORMED BSAC CEFOXITIN 10 DISC AND OBTAINED A REDUCED ZONE OF 19MM (RESISTANT). (B)(6) STATED ALL BLOOD CULTURES ARE PLATED ONTO CHBA, CHOC AND CLED (NONE OF WHICH ARE VALIDATED FOR USE WITH THE VITEK 2 SYSTEM). THE CONSULTANT MICROBIOLOGIST CONFIRMED THE VITEK 2 AST-P635 TEST KIT RESULT DID NOT AFFECT THE PATIENT OUTCOME. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) AST-P635 TEST KIT AST-P635 TEST KIT LON BIOMERIEUX, INC 735367510

    Patients

    Seq Age Sex Outcome Treatment
    1 Death