BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P631 TEST KIT

    MDR report key: 6503900 · Received April 19, 2017

    Report

    Report Number
    1950204-2017-00121
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Report Date
    April 18, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED. TO DETERMINE THE INTENDED RESULT, PCR MECA/MEC C WAS PERFORMED AND A POSITIVE RESULT CONFIRMED THE DETECTION OF (B)(6). A SLIDEX AGGLUTINATION TEST WAS PERFORMED AND CONFIRMED A (B)(6). REFERENCE METHODS WERE TESTED INCLUDING THE AGAR DILUTION(AD) METHOD (USED FOR THE DEVELOPMENT OF OXACILLIN(OX101N), AND DISK DIFFUSION (USED FOR CEFOXITIN SCREEN TEST (FOX)) TO DETERMINE THE PHENOTYPIC INTENDED RESULT. THE INVESTIGATION COMPARED VITEK® 2 RESULTS OF THE CUSTOMER LOTS 731398310 AND 7310067103, AND RANDOM LOT 7731391910 WITH THE AES PARAMETERS USED BY THE CUSTOMER, AND WITH CASFM EUCAST 2015. THE OXA BREAKPOINTS CASFM EUCAST V2 ON V7.01: OXACILLIN [S</=2 R >2] AND CLSI DIAMETER FOR CEFOXITINE >/=22 S ; <22 R. *FROM MASS SPECTROMETRY: THE OXA MIC : 0.5 MG/L S (CL1, CL2 AND RL FROM CPSE PLATES) AND <= 0.25 S (RL FROM CBA PLATE) ARE IN ESSENTIAL AGREEMENT WITH THE REFERENCE MIC (AD= 0.5 MG/L) WITH NO CATEGORY ERROR. THE OXSF TEST IS DISCREPANT WITH THE DISC DIFFUSION (FOX KB=20 MM R) AND DOES NOT ALLOW THE DETECTION OF(B)(6). *AFTER INDUCTION, THE OXA MIC OF 1 OR 2 MG/L S (CL1, CL2 AND RL FROM CPSE PLATES) AND <= 0.25 S (RL FROM CBA PLATE) ARE IN ESSENTIAL AGREEMENT ERROR WITH THE REFERENCE MIC (AD=16 MG/L ) WITH A VERY MAJOR ERROR. THE OXSF TEST IS DISCREPANT WITH THE DISC DIFFUSION (FOX KB=20 MM R) BUT THE (B)(6) PHENOTYPE IS PROPOSED BY AES. THE CUSTOMER RESULTS OF OXA S AND OXSF FALSE NEGATIVE WITH THE MASS SPEC AND THE INDUCIBLE COLONY WERE DUPLICATED. THE PHENOTYPE (B)(6) WAS NOT DETECTED BEFORE INDUCTION. THE PRESENCE OF HETEROGENEOUS RESISTANCE WAS DETECTED. CUSTOMER RESULTS WERE DUPLICATED AND THE AST-P631 CARDS DID NOT PERFORM AS INTENDED (OXSF FALSE NEGATIVE BEFORE INDUCTION).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE OXACILLIN RESULT FOR A STAPHYLOCOCCUS AUREUS ISOLATE FROM A URINE SAMPLE IN ASSOCIATION WITH THE VITEK® 2 AST-P631 TEST KIT (LOT 7310067103). THE ISOLATE WAS TESTED TWICE AND THE RESULTS WERE BENZYLPENICILLINE RESISTANT, CEFOXITIN SCREEN NEGATIVE AND OXACILLIN SUSCEPTIBLE. THE ISOLATE WAS CEFOXITIN RESISTANT USING THE DISK DIFFUSION METHOD AND PLP POSITIVE ON PCR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286087 VITEK® 2 AST-P631 TEST KIT VITEK® 2 AST-P631 TEST CARD LON BIOMERIEUX, INC 7310067103

    Patients

    Seq Age Sex Outcome Treatment
    1