BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P626 TEST KIT

    MDR report key: 8161962 · Received December 13, 2018

    Report

    Report Number
    1950204-2018-00676
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Report Date
    April 24, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN (B)(6) DUE TO A REPORT OF FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULTS FOR THREE PATIENT STRAINS OF STAPHYLOCOCCUS AUREUS ASSOCIATED WITH VITEK® 2 SYSTEM V8.01 SOFTWARE, AND VITEK® 2 AST-P626 CARD. THE LAB REPORTS RECEIVED FROM THE CUSTOMER FOR TESTING PERFORMED USING THE VITEK 2 AST-P626 CARDS WERE FROM LOTS: 5360458103 (EXPIRED), 5360424103 (EXPIRED), AND 5360438103 (EXPIRED). SINCE CUSTOMER LOTS (CL: 5360723103 AND CL: 5360662103) WERE NOT EXPIRED AT THE TIME OF THIS INVESTIGATION AND HAD EACH BEEN USED BY THE CUSTOMER, THESE LOTS WERE SELECTED ALONG WITH A RANDOM LOT (RL: 5360837203), FOR TESTING OF THIS INVESTIGATION. THE CUSTOMER'S STRAINS WERE AS FOLLOWS: 70121855 (911806), 71167930 (911807), 71541361 (911808). IDENTIFICATION WAS CONFIRMED FOR ALL THREE OF THE CUSTOMER'S STRAIN AS STAPHYLOCOCCUS AUREUS VIA VITEK® MS, MATRIX ASSISTED LASER DESORPTION IONIZATION-TIME OF FLIGHT (MALDI-TOF) MASS SPECTROMETRY. THE FOLLOWING REFERENCE METHODS WERE USED TO DETERMINE THE INTENDED RESULT: · KIRBY-BAUER CEFOXITIN (FOX KB), REFERENCE METHOD USED FOR CEFOXITIN SCREEN TEST (OXFS01N) WITH CLSI DIAMETERS BREAKPOINTS USED IN DEVELOPMENT [>= 22 MM S; <= 21 MM R] · OXACILLIN (OX) AGAR DILUTION (AD), REFERENCE METHOD USED FOR THE DEVELOPMENT OF OX ON THE AST-P626 CARDS ADDITIONAL TESTING VIA THE PBP2A METHOD WAS CONDUCTED TO DETERMINE THE PRESENCE OF (B)(6). THE RESULTS FOR REFERENCE TEST METHODS FOX KB AND OX AD, AND THE ADDITIONAL TEST METHOD PBP2A WERE AS FOLLOWS: 70121855 (911906): FOX KB DIAMETER = 24 MM (S), AD OX MIC = 0.5 MG/L, PBP2A NEGATIVE 71167930 (911907): FOX KB DIAMETER = 23 MM (S), AD OX MIC = 0.25 MG/L, PBP2A NEGATIVE 71541361 (911908): FOX KB DIAMETER = 23 MM (S), AD OX MIC = 0.5 MG/L, PBP2A NEGATIVE ANTIBIOTIC SUSCEPTIBILITY TESTING WAS PERFORMED USING THE VITEK 2 SYSTEM SOFTWARE VERSION V08.01, AND THE VITEK 2 AST-P26 CARD. THREE AST-P626 CARD LOTS (MENTIONED ABOVE), INCLUDING TWO CUSTOMER LOTS (CL: 5360723103 AND CL: 5360662103) AND A RANDOM LOT (RL: 5360837203) WERE TESTED. REMEL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD WAS USED TO PERFORM SUBCULTURE. THE OXSF RESULTS FOR BOTH THE CUSTOMER LOTS, AND THE RANDOM LOT RESULTED IN NEGATIVE CEFOXITIN SCREEN TESTS FOR ALL CARDS TESTED WERE NEGATIVE FOR ALL THREE STRAINS TESTED. ALL OF THE OX AND OXFS RESULTS WERE IN BOTH ESSENTIAL AND CATEGORY AGREEMENT. THE VITEK 2 RESULTS FOR OXFS AND OX ARE LISTED BELOW: 70121855 (911906), OXSF NEGATIVE (3 RESULTS), OX MIC <= 0.25 MG/L (3 RESULTS) 71167930 (911907), OXSF NEGATIVE (3 RESULTS), OX MIC = 0.5 MG/L (2 RESULTS) AND MIC <= 0.25 MG/L (1 RESULT) 71541361 (911908), OXSF NEGATIVE (3 RESULTS), OX MIC = 0.5 MG/L (2 RESULTS) AND MIC <= 0.25 MG/L (1 RESULT) IN CONCLUSION, THE CUSTOMER'S FALSE POSITIVE CEFOXITIN SCREEN RESULTS WERE NOT REPRODUCED INTERNALLY.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE POSITIVE CEFOXITIN SCREEN FOR STAPHYLOCOCCUS AUREUS STRAINS A IN ASSOCIATION WITH THE VITEK® 2 AST-P626 TEST KIT. THE CUSTOMER FIRST REPORTED THE ISSUE WHEN TESTING THE STAPHYLOCOCCUS AUREUS (ATCC 29213) INTERNAL QUALITY CONTROL STRAIN, BUT NOW REPORTS THE CEFOXITIN SCREEN WAS POSITIVE AND (B)(6) FOR THREE PATIENT STRAINS ((B)(6), (B)(6), (B)(6)). 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 THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999209 VITEK® 2 AST-P626 TEST KIT VITEK® 2 AST-P626 TEST KIT. LON BIOMERIEUX, INC. 5360424103

    Patients

    Seq Age Sex Outcome Treatment
    1