BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-P619 TEST KIT

    MDR report key: 9410860 · Received December 4, 2019

    Report

    Report Number
    1950204-2019-00321
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Report Date
    April 3, 2020
    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 · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P619 TEST KIT (REF 411944, LOT 4991099103). POSITIVE CEFOXITIN SCREEN RESULTS WERE OBTAINED DURING INITIAL AND REPEAT TESTING. THE CUSTOMER'S STRAIN WAS SUBMITTED FOR INVESTIGATION AND THE IDENTIFICATION WAS CONFIRMED TO BE STAPHYLOCOCCUS AUREUS WITH THE VITEK® 2 GP ID TEST KIT. ALTERNATIVE METHODS: PCR MECA/MECC = NEGATIVE. CEFOXITIN DISK DIFFUSION: D =25 MM (SUSCEPTIBLE). REFERENCE METHODS: OXACILLIN AGAR DILUTION: OX MIC = 1 MG/L (SUSCEPTIBLE). CEFOXITIN BROTH MICRODILUTION: MIC = 8 MG/L (RESISTANT). THE STRAIN WAS TESTED WITH THE VITEK® 2 AST-P619 TEST KIT FROM THE CUSTOMER'S LOT (4991099103, CALLED CL) AND A RANDOM LOT (CALLED RL). POSITIVE OXSF TEST RESULTS AND ¿MODIFICATION OF PBP¿ PHENOTYPES WERE OBTAINED ON THE TWO LOTS TESTED. OX MIC = 1 MG/L (SUSCEPTIBLE) WERE OBTAINED ON THE CL AND OX MIC = 0.5 MG/L (SUSCEPTIBLE) ON THE RL. THESE OX VALUES ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE AD MIC (1 MG/L) WITHOUT ANY CATEGORY ERROR. THE OXACILLIN IS CORRECTED TO R BY THE AES. THIS CORRECTION IS DUE TO THE POSITIVE OXSF TEST RESULTS AND THE ¿MODIFICATION OF PBP¿ PHENOTYPE. CONCLUSION: THE CUSTOMER POSITIVE OXSF TESTS ON AST-P619 CARD ARE REPRODUCED IN-HOUSE. THE STRAIN IS SUSPECTED TO BE A BORSA (BORDERLINE OXACILLIN RESISTANT S. AUREUS), AND WILL BE ADDED TO THE R&D STOCK COLLECTION. AST-P619 LOT 4991099103 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.SEE H10 FOR ADDTL MFG NARRATIVE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P619 TEST KIT (REF 411944, LOT 4991099103). POSITIVE CEFOXITIN SCREEN RESULTS WERE OBTAINED DURING INITIAL AND REPEAT TESTING. INITIAL TESTING WAS PERFORMED UNDER CONDITIONS NOT RECOMMENDED IN THE INSTRUCTIONS FOR USE (OFF-LABEL USE). REPEAT TESTING WITH THE VITEK® 2 AST-P619 TEST KIT CARDS WAS PERFORMED UNDER RECOMMENDED CONDITIONS AND STILL OBTAINED FALSE POSITIVE CEFOXITIN SCREEN RESULTS. ALTERNATIVE TEST RESULTS: PBP2A = NEG. MECA = NEG. MECC = NEG. DISK DIFFUSION CEFOXITIN (FOX) = 26 MM. THE CUSTOMER REPORTED THAT THE FALSE POSITIVE RESULTS LED TO A DELAY OF >24 HOURS IN REPORTING RESULTS TO THE PHYSICIAN, BUT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207676 VITEK 2 AST-P619 TEST KIT AST-P619 TEST KIT 20 CARDS - 411944 LON BIOMERIEUX, INC. 4991099103

    Patients

    Seq Age Sex Outcome Treatment
    1