BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 5265592 · Received December 3, 2015

    Report

    Report Number
    1950204-2015-00112
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Report Date
    November 16, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ISOLATES (2) WERE SUBCULTURED AND TESTING INCLUDED THE FOLLOWING. ISOLATE 1: GN ID CARD FROM THE SAME LOT AS THAT TESTED BY THE CUSTOMER - VERY GOOD IDENTIFICATION CALLS OF KLEB PNEUMONIAE SSP OZAENAE. GN ID CARD FROM A RANDOM LOT - VERY GOOD IDENTIFICATION CALLS OF KLEB PNEUMONIAE SSP OZAENAE. API® 20E - LOW DISCRIMINATION CALL BETWEEN ENT CLOACAE (54.9%) AND KLEB PNEUMONIAE (31.5%). 16S SEQUENCING - IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. VITEK® MS - IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. ISOLATE 2: GN ID CARD FROM THE SAME LOT AS THAT TESTED BY THE CUSTOMER - UNIDENTIFIED ORGANISM GN ID CARD FROM A RANDOM LOT - IDENTIFICATION OF PANTOEA AGGLOMERANS. API® 20E - DOUBTFUL PROFILE WITH THE CHOICES INCLUDING KLEBSIELLA PNEUMONIAE (27.2%) / PANTOEA 1(18.5%) / PSEUDOMONAS LUTEOLA (18.4%) / PANTOEA 3 (18.4%). 16S SEQUENCING - KLEBSIELLA PNEUMONIAE. REVIEW OF THE PANTOEA DATA AGAINST THE EXPECTED REACTIONS FOR KLEBSIELLA PNEUMONIAE SHOW THE PANTOEA DATA TO HAVE 19 ATYPICAL NEGATIVE REACTIONS. THIS BEHAVIOR SUGGESTS VERY SLOW ORGANISM GROWTH WHICH IS NOT CONDUCIVE TO PHENOTYPIC AST TESTING METHODS. BOTH 16S SEQUENCING AND VITEK® MS USE GENETIC MEASUREMENT TECHNIQUES AND ARE MORE CONDUCIVE TO TESTING CERTAIN SLOWER-GROWTH ORGANISMS. THE INVESTIGATION DID NOT REPRODUCE THE CUSTOMER'S IDENTIFICATION OF PSEUDOMONAS LUTEOLA. THE VITEK® 2 GN ID CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. VITEK® 2 GN ID RESULT - PSEUDOMONAS LUTEOLA, API® 20E - LOW DISCRIMINATION PASTEURELLA/OCHROBACTRUM/STENOTROPHOMONAS, API® 20E (REPEAT TEST) - LOW DISCRIMINATION PASTEURELLA/PANTOEA, MALDI-TOF - KLEBSIELLA PNEUMONIAE. IT IS NOT KNOWN WHICH, IF ANY, RESULT WAS REPORTED TO THE TREATING PHYSICIAN. HOWEVER, 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. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796191 VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD JTO BIOMERIEUX, INC 241355340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other