BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P580 TEST KIT

    MDR report key: 8595801 · Received May 9, 2019

    Report

    Report Number
    1950204-2019-00128
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) TESTED A STAPHYLOCOCCUS AUREUS STRAIN AND OBTAINED A FALSE RESISTANT OXACILLIN RESULT WITH INITIAL TESTING USING THE VITEK® 2 AST-P580 TEST KIT (REFERENCE # 22233 LOT # 3600816403) WITH VITEK® 2 V8.01 SOFTWARE. REPEAT TEST RESULTS WERE OXACILLIN SUSCEPTIBLE. DISK DIFFUSION WAS OXACILLIN SUSCEPTIBLE. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE ISOLATE (M190027965, BMX STOCK NO# 911996) WAS RECEIVED AND SUB-CULTURED TO TSAB AGAR. ISOLATE IDENTIFICATION WAS CONFIRMED TO BE STAPHYLOCOCCUS AUREUS VIA VITEK® MS. ALL VITEK® 2 CARD TESTING WAS PERFORMED WITH VITEK® 2 V8.01 SOFTWARE. TESTING VIA AST P580 CARD INCLUDED THE CUSTOMER LOT AND TWO (2) RANDOM LOTS. - CUSTOMER LOT 3600816403 (CL) - CEFOXITIN SCREEN (OXSF) NEGATIVE (MODIFIED TO POSITIVE BY ADVANCED EXPERT SYSTEM¿), OXACILLIN MIC>=4 (RESISTANT) - RANDOM LOT 3600997203 (RL1) - OXSF NEGATIVE, OXACILLIN MIC=1 (SUSCEPTIBLE) - RANDOM LOT 3600753403 (RL2) - OXSF NEGATIVE (MODIFIED TO POSITIVE BY ADVANCED EXPERT SYSTEM¿), OXACILLIN MIC>=4 (RESISTANT) ALTERNATE METHOD TESTING RESULTS: - OXACILLIN AGAR DILUTION - MIC = 0.5, SUSCEPTIBLE - CEFOXITIN DISK = NEGATIVE, ZONE DIAMETER OF 24MM - PBP2A TESTING = NEGATIVE, INDICATING THAT THIS ISOLATE IS MSSA THIS REPRESENTS AN ESSENTIAL AND CATEGORICAL AGREEMENT ERROR FOR 2 OF 3 CARDS TESTED (CL AND RL2) WHILE CARDS FROM RL1 ARE IN BOTH CATEGORICAL AND ESSENTIAL AGREEMENT. THE CUSTOMER'S DISCREPANT FALSE RESISTANT OXACILLIN RESULT WAS REPRODUCED. THE INVESTIGATION CONCLUDED THE ISOLATE IS AN ATYPICAL STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A (B)(6) RESULT FOR (B)(6) WHEN PERFORMING ANTIBIOTIC SUSCEPTIBILITY TESTING FOR A PATIENT STRAIN USING THE VITEK® 2 AST-P580 TEST KIT (REFERENCE 22233), LOT 3600816403, WITH VITEK® 2 V8.01 SOFTWARE. THE CUSTOMER REPORTED OBTAINING THE FOLLOWING RESULTS FOR A PATIENT ISOLATE FROM A WOUND SAMPLE: STRAIN ID: (B)(6). ISOLATE ID: (B)(6). INITIAL VITEK 2 AST-P580 CARD: (B)(6). REPEAT VITEK 2 AST-P580 CARD: (B)(6). ALTERNATE TEST METHOD: OXACILLIN DISK DIFFUSION - SUSCEPTIBLE; CEFOXITIN DISK DIFFUSION - SUSCEPTIBLE THE CUSTOMER REPORTED THAT THERE WAS NO DELAY IN REPORTING RESULTS, NO WRONG RESULTS REPORTED TO THE PHYSICIANS, NO DELAY IN TREATMENT DECISION, AND THAT NO PATIENT WAS HARMED OR TREATED INCORRECTLY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391000 VITEK® 2 AST-P580 TEST KIT VITEK® 2 AST-P580 TEST KIT LON BIOMERIEUX, INC. 3600816403

    Patients

    Seq Age Sex Outcome Treatment
    1