BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT

    MDR report key: 8553061 · Received April 25, 2019

    Report

    Report Number
    1950204-2019-00106
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULTS IN ASSOCIATION WITH STAPHYLOCOCCUS AUREUS ISOLATES USING THE VITEK® 2 AST-P580 TEST KIT (REF # 22233 LOT# 3600816403 AND 3600753403). THE ISOLATES (M190024082, BIOMÉRIEUX STOCK NO# 911994 AND M190026465, BIOMÉRIEUX STOCK NO# 911995) WERE RECEIVED AND SUBBED TO REMEL TSAB AGAR. ISOLATE IDENTIFICATION WAS CONFIRMED TO BE STAPHYLOCOCCUS AUREUS VIA VITEK MS. INTERNAL TESTING INCLUDED: - VITEK 2 CARDS FROM THE CUSTOMER LOTS (3600816403 AND 3600753403) AND RANDOM LOT 3600753403 (RL) - OXACILLIN AGAR DILUTION TESTING (REFERENCE METHOD FOR OXACILLIN, OX101N DEVELOPMENT) - CEFOXITIN DISK TESTING (REFERENCE METHOD FOR CEFOXITIN SCREEN, OXFS01N, AST-P580 DEVELOPMENT) - PBP2A TESTING. FOR THE VITEK 2 AST-P580 CEFOXITIN SCREEN AND OXACILLIN CARD TESTING, ALL CARDS TESTED GAVE A NEGATIVE CEFOXITIN SCREEN RESULT AND AN OXACILLIN MIC OF 0.5. ALL VITEK CARD TESTING WAS PERFORMED WITH VERSION 8.01 SOFTWARE. INTERNAL CEFOXITIN DISK REFERENCE METHOD TESTING WAS CONDUCTED RESULTING IN A NEGATIVE TEST WITH A ZONE DIAMETER OF 23MM FOR BOTH 911994 AND 911995. OXACILLIN AGAR DILUTION REFERENCE METHOD TESTING WAS CONDUCTED AND RESULTED IN A SUSCEPTIBLE MIC OF 0.5 FOR BOTH 911994 AND 911995. THIS REPRESENTS AN ESSENTIAL AND CATEGORICAL AGREEMENT FOR ALL CARDS TESTED. ADDITIONALLY, THE PBP2A TESTING WAS NEGATIVE INDICATING THAT THIS ISOLATE IS (B)(6). A REVIEW OF THE CUSTOMER'S SUBMITTED DATA OF THE TWO REPLICATES SHOWED THE ONE CALLED POSITIVE WAS VERY CLOSE (BORDER LINE) TO CALLING NEGATIVE. BOTH ISOLATES CEFOXITIN SCREEN RESULTS WERE CALLED AT A LITTLE OVER 12 HOURS. GRAPH REVIEW OF INTERNAL VITEK 2 TESTING DID NOT SHOW ANY GROWTH IN THE CEFOXITIN SCREEN WELLS PRIOR TO CALLING NEGATIVE. IN CONCLUSION, THE CUSTOMER'S FALSE POSITIVE CEFOXITIN SCREEN RESULTS WERE NOT DUPLICATED AND THE VITEK 2 AST-P580 CARD PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE CEFOXITIN SCREEN (OXFS) RESULT IN ASSOCIATION WITH A STAPHYLOCOCCUS AUREUS ISOLATE USING THE VITEK® 2 AST-P580 TEST KIT (REF # 22233 LOT# 3600753403). THE CUSTOMER PERFORMED SUSCEPTIBILITY RETESTING USING THE SAME LOT OF AST-P580 CARDS AS WELL AS PERFORMING DISC DIFFUSION AND AN ETEST® THE RESULTS ARE AS FOLLOWS: ISOLATE SUSCEPTIBILITY RESULTS: INITIAL TEST WITH P580: OXFS POSITIVE (RESISTANT). REPEAT TEST WITH P580: OXFS NEGATIVE (SUSCEPTIBLE). DISC DIFFUSION: SENSITIVE (SUSCEPTIBLE). ETEST MINIMUM INHIBITORY CONCENTRATION (MIC): MIC=4 SENSITIVE (SUSCEPTIBLE). THE REPEAT VITEK 2 AST TEST, DISC DIFFUSION, AND ETEST RESULTS INDICATE THAT THIS ISOLATE IS CEFOXITIN SENSITIVE AND THE INITIAL RESULT WAS INCORRECT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345862 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT VITEK® 2 AST-P580 CARD LON BIOMERIEUX, INC 3600753403

    Patients

    Seq Age Sex Outcome Treatment
    1