BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N340 TEST KIT

    MDR report key: 7039439 · Received November 16, 2017

    Report

    Report Number
    1950204-2017-00387
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Report Date
    March 20, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S82
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS INITIATED DUE TO DISCREPANT RESULTS ON VITEK®2 V7.01 AST- N340 CARD FOR AMOXICILLIN/CLAVULANIC (AMC), CEFTAZIDIME (CAZ) AND PIPERACILLIN/ TAZOBACTAM (TZP) WITH A STRAIN OF KLEBSIELLA PNEUMONIAE. AGAR DILUTION (AD) WITH AN INCREASED CONCENTRATION OF CLAVULANATE ACID WHICH WAS THE METHOD USED FOR AMC01N DEVELOPMENT ON AST-N340 CARD ACCORDING TO CLSI : AMC MIC = 4/2 MG/L S . AGAR DILUTION (AD) WHICH WAS THE METHOD USED FOR CAZ01N DEVELOPMENT ON AST-N340 CARD : CAZ MIC = 0.5 MG/L S. BROTH MICRODILUTION (BMD) WITH A CONSTANT CONCENTRATION OF TAZOBACTAM, WHICH WAS THE METHOD USED FOR TZP03N DEVELOPMENT ON THIS CARD : MIC = 4/4 MG/L S. PRODUCT & SYSTEM INCRIMINATED VITEK 2 V7.01 (AES PARAMETERS : CASFM EUCAST 2016 + PHENOTYPIC). TWO (2) CARDS (ONE FROM THE CUSTOMER LOT 7800427203 CL AND ONE FROM A RANDOM LOT 7800341103 RL) WERE TESTED. FOR CAZ : THE CAZ VALUE ([?] 1 MG/L S) IS WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE MIC (AD = 0.5 MG/L S), AND NO CATEGORY ERROR. CUSTOMER RESULT WAS NOT REPRODUCED FOR CAZ (CAZ MIC = 2MG/L I). CONCLUSION : FOR AMC AND CAZ, THE RESULTS ARE IN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE METHODS (AGAR DILUTION). INTERMEDIATE & RESISTANT CUSTOMER RESULTS WERE NOT REPRODUCED. THE RDCS STUDY CONFIRMS A SLIGHT OVERESTIMATION OF PIPERACILLIN/ TAZOBACTAM (+2 DOUBLING DILUTIONS COMPARED TO BMD), WHICH LEADS TO A MINOR ERROR OF CATEGORY ONLY ON THE CUSTOMER LOT. ON THE RANDOM LOT, THE TZP RESULT IS WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE METHOD (BMD). INTERMEDIATE CUSTOMER RESULT FOR TZP IS THEN PARTIALLY CONFIRMED (1/ 2 LOTS). VITEK 2 AST-N340 CARDS PERFORMED AS INTENDED FOR AMC AND CAZ; MINOR CATEGORY ERROR FOR TZP.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX DISCREPANT CEFTAZIDIME (CAZ) RESULTS FOR A KLEBSIELLA PNEUMONIAE SAMPLE IN ASSOCIATION WITH THE VITEK® 2 AST-N340 TEST KIT (LOT 7800427203). THE CUSTOMER STATED THERE WAS NO MUTANT RESISTANCE DETECTED FOR CAZ AND AMC (AMOXICILLIN) BY VITEK® 2. THE CUSTOMER REPORTED TESTING WITH TWO CARDS, USING CPS AND COS MEDIA. THE RESULTS WERE: FIRST CARD: VITEK® 2: CAZ = CMI </=1 S, WITH AMC CMI =8 S. DISC DIFFUSION : CAZ DIAMETER = 19 MM I WITH COLONY OF MUTANT RESISTANT, AMC DIAMETER =11 R. PHENOYPE DETECTED PASE ACQUIRED. SECOND CARD: VITEK® 2: CAZ = CMI 2 I, AND AMC >16 R. DISC DIFFUSION: CAZ DIAMETER =13MM R AND AMC=10MM R. PHENOTYPE DETECTED: BLSE, HYPER SHV1. (CASFM 2016 : CMI S <=1 R>4 ET DIFFUSION S>=22 MM R <(><<)>19). THE CUSTOMER STATED THAT AN INCORRECT RESULT WAS NOT REPORTED TO THE CLINICIAN, AND PATIENT RESULTS AND TREATMENT WERE NOT IMPACTED. THE CUSTOMER REPORTED THERE WAS A DELAY GREATER THAN 24 HOURS FOR REPORTING RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817737 VITEK® 2 AST-N340 TEST KIT VITEK® 2 AST-N340 TEST KIT LON BIOMERIEUX, INC 7800427203

    Patients

    Seq Age Sex Outcome Treatment
    1