BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P654 TEST KIT

    MDR report key: 8620504 · Received May 17, 2019

    Report

    Report Number
    1950204-2019-00150
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED IN RESPONSE TO A CUSTOMER COMPLAINT FOR FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-P654 TEST KIT (REF (B)(6), LOT 8040935203). THE CUSTOMER PROVIDED 2 STRAINS FOR INVESTIGATIONAL TESTING. THE STRAINS WERE CONFIRMED TO BE STAPHYLOCOCCUS AUREUS, USING THE VITEK® 2 GP ID TEST KIT (LOT 2420906203). INVESTIGATIONAL TESTING INCLUDED TESTING THE STRAINS USING REFERENCE METHODS AS WELL AS ANALYZING THE STRAIN USING THE VITEK® 2 AST-P654 TEST KIT FROM THE CUSTOMER'S LOT (8040935203) AND A RANDOM LOT (8040873203). REFERENCE TEST RESULTS: STRAIN 1 - PCR MECA/MECC = NEG, STRAIN 2 - PCR MECA/MECC = NEG. STRAIN 1 - AGAR DILUTION (AD): OX MIC = 0.25 MG/L (SUSCEPTIBLE), STRAIN 2 - AGAR DILUTION (AD): OX MIC = 0.5 MG/L (SUSCEPTIBLE). STRAIN 1 - KIRBY-BAUER CEFOXITIN (FOX KB): D = 26 MM (SUSCEPTIBLE), STRAIN 2 - KIRBY-BAUER CEFOXITIN (FOX KB): D = 23 MM (SUSCEPTIBLE). VITEK® 2 AST-P654 RESULTS: CUSTOMER'S LOT (8040935203): STRAIN 1 - OX MIC = 0.5 MG/L (SUSCEPTIBLE), STRAIN 2 - OX MIC = 0.5 MG/L (SUSCEPTIBLE). STRAIN 1 - CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE), STRAIN 2 - CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE). RANDOM LOT (8040873203): STRAIN 1 - OX MIC = 0.5 MG/L (SUSCEPTIBLE), STRAIN 2 - OX MIC = 0.5 MG/L (SUSCEPTIBLE). STRAIN 1 - CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE), STRAIN 2 - CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE). CONCLUSIONS: THE OX AND OXSF RESULTS OBTAINED FROM VITEK® AST-P654 TESTING ARE IN AGREEMENT WITH THE REFERENCE METHODS. THE CUSTOMER'S FALSE POSITIVE OXSF RESULTS ON AST-P654 CARD WERE NOT REPRODUCED INTERNALLY. THE VITEK® 2 AST P654 TEST KIT CARDS ARE PERFORMING AS EXPECTED. AST-P654, LOT # 8040935203 MET FINAL QC RELEASE CRITERIA. THE LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF THREE FALSE (B)(6) CEFOXITIN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS ISOLATES FROM SEPARATE PATIENTS WHILE USING THE VITEK® 2 AST-P654 TEST KIT (REF# (B)(4), LOT# 8040935203) WITH SOFTWARE VERSION 8.01. THE ISOLATES WERE REPEATED ON THE VITEK 2 WITH THE SAME LOT OF CARDS AND ALSO TESTED USING ALTERNATE TEST METHODS CEFOXITIN DISK DIFFUSION AND MECA/MECC PCR. THE RESULTS FOR ISOLATE 1 ARE LISTED BELOW: ISOLATE 1: SAMPLE SOURCE: SWAB. ORIGINAL VITEK 2 RESULT: OXACILLIN MINIMUM INHIBITORY CONCENTRATION (MIC)= 0.5, OXSF (B)(6) -RESISTANT. REPEAT VITEK 2 RESULT: OXACILLIN MIC= 0.5, OXSF (B)(6) - RESISTANT. CEFOXITIN DISK DIFFUSION RESULT - 28MM - SENSITIVE. MECA/MECC PCR RESULT - (B)(6) - SENSITIVE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT. NO WRONG RESULT WAS REPORTED. THE CUSTOMER STATED THERE WAS NO DELAY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412858 VITEK® 2 AST-P654 TEST KIT VITEK® 2 AST-P654 TEST KIT LON BIOMERIEUX, INC. 8040935203

    Patients

    Seq Age Sex Outcome Treatment
    1