BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

    MDR report key: 4534386 · Received February 23, 2015

    Report

    Report Number
    1950204-2015-00002
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    February 14, 2015
    Report Date
    February 19, 2015
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    SEE SEC. H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) INFORMATION: VANCOMYCIN - 510(K) NUMBER IS K072668. TEICOPLANIN - N/A (EXPORT ONLY). NITROFURANTOIN - PMA NUMBER IS N50510 S116. TETRACYCLINE - PMA NUMBER IS N50510 S85. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THREE STRAINS (S1, S2, S3) OF STREPTOCOCCUS AGALACTIAE WERE SUBMITTED BY THE CUSTOMER FOR INSUFFICIENT GROWTH FOR INTERPRETATION (TRM) OF TEICOPLANIN, VANCOMYCIN & NITROFURANTOIN WITH AST-P606 CARDS. INVESTIGATIONAL TESTING WAS PERFORMED. CONFIRMATION OF ORGANISM IDENTIFICATION (STREPTOCOCCUS AGALACTIAE) FOR THESE ISOLATES WAS PERFORMED VIA VITEK MS, RAPID (B)(4) STRIP (S2 REPORTED DOUBTFUL PROFILE WITH ADH TEST AGAINST) AND WITH SLIDEX STREPTO KIT. ISOLATE SAMPLE #1 AND #3 WERE IDENTIFIED CORRECTLY USING THE VITEK 2 GRAM POSITIVE TEST KIT. ISOLATE SAMPLE #2 WAS MISIDENTIFIED WITH AN ATYPICAL PROFILE; S. DYSGALACTIAE. SUSCEPTIBILITY TESTING WAS PERFORMED FOR EACH CUSTOMER SUBMITTED ISOLATE STRAIN (S1, S2, S3) WITH THE VITEK 2 AST-P606 TEST KIT, THREE DIFFERENT LOTS (TWO LOTS USED BY THE CUSTOMER, AND A RANDOM LOT). THE INVESTIGATION DID NOT DUPLICATE RESULTS REPORTED BY CUSTOMER REGARDING ISOLATE SAMPLE #1 AND #3; MICS WERE OBTAINED FOR TEICOPLANIN, VANCOMYCIN AND NITROFURANTOIN. THE RESULTS REPORTED BY THE CUSTOMER WERE DUPLICATED FOR ISOLATE SAMPLE #2; TERMINATED ANTIBIOTICS FOR TEICOPLANIN, VANCOMYCIN AND NITROFURANTOIN. ALSO TESTED WERE TWO INTERNAL STRAINS OF STREPTOCOCCUS AGALACTIAE AND CONFIRMED A GOOD INTERPRETATION OF MIC FOR TEICOPLANIN, VANCOMYCIN AND NITROFURANTOIN FOR EACH STRAIN. THE INVESTIGATION ACTIVITIES (TESTING OF ORGANISM AND ANALYSIS OF GRAPHICAL GROWTH PATTERNS) DETERMINED THAT STRAIN S2 TERMINATED DUE TO POOR GROWTH IN THE POSITIVE CONTROL WELL, RESULTING IN INSUFFICIENT GROWTH TO ACCURATELY DETERMINE THE MIC. IN THIS EVENT, THE USER IS PROVIDED AN ANALYSIS MESSAGE/WARNING THAT THERE IS "INSUFFICIENT GROWTH IN THE POSITIVE CONTROL WELL" FOR CONTINUED ANALYSIS AND NO RESULTS WILL BE PROVIDED FOR ASSOCIATED ANTIBIOTICS. THE USER WILL BE REQUIRED TO PERFORM TESTING VIA ALTERNATE AST METHOD FOR THE ANTIBIOTICS IMPACTED. THE AST-P606 TEST KIT IS PERFORMING AS EXPECTED, AND THE ISOLATE IS CONSIDERED ATYPICAL DUE TO ITS POOR GROWTH IN THE POSITIVE CONTROL WELL. POSSIBLE REASONS FOR ATYPICAL GROWTH RANGE FROM EXPOSURE TO ANTIBIOTIC IN THE PATIENT TO MUTATION OF ONE OR MORE OF THE GENES REQUIRED FOR RAPID GROWTH.

    Description of Event or Problem · 1

    A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF EXCESSIVE ANTIBIOTIC TERMINATIONS (VANCOMYCIN, TEICOPLANIN, NITROFURANTOINE) FOR STREPTOCOCCUS B ORGANISMS WHEN USING THE VITEK® 2 AST-P606 TEST KIT. THE CUSTOMER ALSO CLAIMS POOR REPRODUCIBILITY OF TETRACYCLINE CATEGORY RESULTS. THE CUSTOMER STATES THEIR INTERNAL QUALITY CONTROL CONTINUOUSLY PASSES, EVEN THOUGH THEY EXPERIENCE THE REPORTED ISSUES. FOR THIS SPECIFIC RECORD, THE ORGANISM UNDER TEST IS STREPTOCOCCUS AGALACTIAE. THERE HAS BEEN NO INDICATION FROM THE CUSTOMER THAT THE TERMINATION OF ANTIBIOTIC RESULTS (VANCOMYCIN, TEICOPLANIN, NITROFURANTOINE) OR THE TETRACYCLINE RESULT VIA THE VITEK® 2 AST-P606 CARD HAS LED TO ADVERSE EVENT OR PATIENT INJURY. THERE HAS ALSO BEEN NO REPORT OF DELAY IN TREATMENT, DELAY IN DIAGNOSIS, OR MEDICAL INTERVENTION REQUIRED. REVIEW OF VITEK® 2 AST-P606 COMPLAINT HISTORY HAS NOT IDENTIFIED ANY OTHER COMPLAINTS ASSOCIATED WITH THE REFERENCED LOT. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED. THIS FILE WILL BE UPDATED AS FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125965 VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT VITEK 2 AST-P606 CARD LON BIOMÉRIEUX, INC. 486327810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention