BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N233

    MDR report key: 4837902 · Received June 11, 2015

    Report

    Report Number
    1950204-2015-00010
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 20, 2015
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    D023817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR SEVEN (7) PATIENT ISOLATES SUBMITTED FOR ERTAPENEM (ETP) SUSCEPTIBILITY TESTING. (B)(4). IDENTIFICATION CONFIRMATION TESTING WAS PERFORMED USING THE VITEK® 2 GN ID CARD: SIX (6) ISOLATES WERE IDENTIFIED AS ENTEROBACTER CLOACAE COMPLEX . ONE (1) ISOLATE (S2) WAS IDENTIFIED ENTEROBACTER ASBURIAE. SUSCEPTIBILITY TESTING INCLUDED THE FOLLOWING METHODS: VITEK 2 AST-N233 (CUSTOMER LOT AND RANDOM LOT). VITEK 2 AST-N235 (TWO RANDOM LOTS). AGAR DILUTION (AD), THE REFERENCE METHOD USED FOR THE DEVELOPMENT OF VITEK 2 ERTAPENEM DEVELOPMENT. ETEST, ALTERNATE METHOD USED BY THE CUSTOMER. RESULTS OF SUSCEPTIBILITY TESTING: ISOLATES S2, S6: ETP S, MIC <=0.5MG/L ON BOTH LOTS OF AST-N233 AND BOTH AST-N235 CARDS; IN AGREEMENT WITH AD (0.5 MG/L). ETEST GAVE A SUSCEPTIBLE RESULT OF 0.5MG/L. THE REPORTED CUSTOMER RESULTS (FALSE SUSCEPTIBLE) WERE NOT DUPLICATED FOR ISOLATES S2 AND S6. ISOLATE S7: ETP S, MIC <=0.5MG/L OR ERT I, MIC=1MG/L ON AST-N233 AND AST-N235 CARDS; IN AGREEMENT WITH AD (0.5 MG/L) WITHIN ONE DOUBLING DILUTION. ETEST GAVE A RESISTANT RESULT OF 2MG/L, MIC OVERESTIMATED COMPARED WITH AD (0.5 MG/L). THE REPORTED CUSTOMER RESULT (FALSE SUSCEPTIBLE) WAS NOT CONFIRMED FOR ISOLATE S7 WHEN COMPARED TO THE REFERENCE METHOD (AD), THOUGH ETEST RESULT WAS RESISANT FOR THIS ISOLATE. ISOLATE S3: ETP S, MIC <=0.5MG/L ON THE CUSTOMER LOT OF AST-N233 AND ON BOTH AST-N235 CARDS; IN AGREEMENT WITH AD (0.25 MG/L) WITHIN ONE DOUBLING DILUTION. ETP I, MIC =1MG/L ON THE RANDOM LOT OF AST-N233; MIC OVERESTIMATED COMPARED TO AD (0.25 MG/L) BY MORE THAN ONE DOUBLING DILUTION. ETEST GAVE AN INTERMEDIATE RESULT OF 1MG/L. THE REPORTED CUSTOMER RESULT (FALSE SUSCEPTIBLE) WAS NOT CONFIRMED FOR ISOLATE S3 WHEN COMPARED TO THE REFERENCE METHOD (AD), THOUGH ETEST RESULT WAS INTERMEDIATE FOR THIS ISOLATE. ISOLATE S4: ETP S, MIC <=0.5MG/L ON BOTH LOTS OF AST-N233 AND ONE AST-N235 CARD; IN AGREEMENT WITH AD (0.25 MG/L) WITHIN ONE DOUBLING DILUTION. ETP I, MIC =1MG/L ON ONE AST-N235 (SECOND TEST) SO MIC OVERESTIMATED COMPARED TO AD 0.25 MG/L). ETEST GAVE AN INTERMEDIATE RESULT OF 1MG/L. THE REPORTED CUSTOMER RESULT (FALSE SUSCEPTIBLE) WAS NOT CONFIRMED FOR ISOLATE S3 WHEN COMPARED TO THE REFERENCE METHOD (AD), THOUGH ETEST RESULT WAS INTERMEDIATE FOR THIS ISOLATE. ISOLATE S1: ETP I, MIC =1MG/L ON THE CUSTOMER LOT OF AST-N233; IN AGREEMENT WITH AD (0.5MG/L) WITHIN 1DOUBLING DILUTION. ETP R, MIC =2MG/L ON THE RANDOM LOT OF AST-N233 AND MIC =4MG/L ON AST-N235. MIC OVERESTIMATED COMPARED TO AD BY MORE THAN ONE DOUBLING DILUTION. ETEST GAVE A SUSCEPTIBLE RESULT 0.25MG/L.. THE REPORTED CUSTOMER RESULT (FALSE SUSCEPTIBLE) WAS NOT CONFIRMED FOR ISOLATE S1. ISOLATE S5: ETP I, MIC =1MG/L ON THE CUSTOMER LOT OF AST-N233 OR ETP I, MIC =0.5MG/L ON AST-N235; IN AGREEMENT WITH AD (0.5MG/L) WITHIN ONE DOUBLING DILUTION. ETP R, MIC =4MG/L ON THE RANDOM LOT OF AST-N233. MIC OVERESTIMATED COMPARED TO AD BY MORE THAN ONE DOUBLING DILUTION. ETEST GAVE A SUSCEPTIBLE RESULT 0.5MGL. THE REPORTED CUSTOMER RESULT (FALSE SUSCEPTIBLE) WAS NOT CONFIRMED FOR ISOLATE S1. THE FALSE SUSCEPTIBLE VITEK 2 ERTAPENEM RESULTS INITIALLY REPORTED BY THE CUSTOMER WERE NOT DUPLICATED DURING THE INTERNAL BIOMÉRIEUX INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE VITEK 2 AST-N233 AND AST-N235 TESTS KITS ARE PERFORMING IN ACCORDANCE WITH PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED (B)(6) TO REPORT A DISCREPANT ERTAPENEM RESULT IN ASSOCIATION WITH THE VITEK® 2 AST-N233 TEST KIT (REF 413117, LOT 633343140, EXPIRY 06MAY16). (B)(6) SUBSEQUENTLY CONTACTED BIOMÉRIEUX. ORGANISM - ENTEROBACTER CLOACAE COMPLEX VITEK® 2 MIC = 0.5MG/L (S), ETEST MIC = 3 MG/L (R) THERE IS NO CLAIM BY THE CUSTOMER THAT THE VITEK® 2 TEST RESULT IS INCORRECT, ONLY THAT A DISCREPANCY OCCURRED. THE CUSTOMER CLAIMS A 48-HOUR DELAY IN REPORTING RESULTS, ALTHOUGH THERE IS NO INDICATION OR REPORT THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL'S HAVE BEEN REQUESTED FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381988 VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N233 VITEK 2 AST-N233 LON BIOMÉRIEUX, INC. 633343140

    Patients

    Seq Age Sex Outcome Treatment
    1