BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® REVEAL¿ SENSOR PANEL

    MDR report key: 22307144 · Received June 23, 2025

    Report

    Report Number
    1950204-2025-00003
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    00860007326929
    PMA / PMN Number
    K230675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT ASSOCIATED WITH THIS MDR WAS INITIALLY DOCUMENTED AGAINST THE VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002). THIS PRODUCT IS REGISTERED WITH FDA UNDER 510(K) K230675. DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS SUBSEQUENTLY DETERMINED THE COMPLAINT WAS IN FACT RELATED TO VITEK® REVEAL¿ GN01-AST (20 TESTS) - 900-00008. THIS PRODUCT IS AN EXPORT-ONLY PRODUCT THAT IS NOT REGISTERED WITH FDA, AND IS NOT DISTRIBUTED IN THE UNITED STATES. THEREFORE THE EVENT IS NOT REPORTABLE TO FDA. THIS SUPPLEMENT REPORT SERVES TO CLOSE THIS RECORD.

    Description of Event or Problem · 0

    INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF DISCORDANT RESULTS FOR CEFTAZIDIME-CLAVULANATE -POTENTIAL FALSE RESISTANT RESULTS IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 101724GWA). CUSTOMER REPORTED THAT WHEN COMPARING THE RESULTS OBTAINED WITH VITEK REVEAL AND MICRODILUTION THE CUSTOMER REPORTED DISCORDANT RESULTS. RESULTS ARE SUMMARIZED BELOW: AST__20250530_1353__R205__A1__LF THE LOT NUMBERS ARE 101724GWA FOR THE SENSOR AND 2025-06-10 ANTIBIOTIC CEFTAZIDIME-CLAVULANATE REPORTED POSITIVE WHILE IT WAS SENSITIVE WITH DIFFUSION DISK. UNDER THE SUSPICION THAT THE VITEK REVEAL RESULTS WERE NOT CORRECT, THEY WERE NOT REPORTED AND THEREFORE DID NOT HAVE ANY EFFECT ON THE TREATMENT OF THE PATIENT. BIOMÉRIEUX LOCAL CUSTOMER SERVICE INDICATED THAT AFTER TAKING A LOOK TO THE TROUBLESHOOTING FILES, SOME LEAK GRAPHS SEEM TO LOOK ABNORMAL, WHICH COULD INDICATE LEAKAGE BETWEEN WELLS. THIS HAS BEEN COMMUNICATED TO THE CUSTOMER. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849084 VITEK® REVEAL¿ SENSOR PANEL VITEK® REVEAL¿ SENSOR PANEL LON BIOMERIEUX, INC. 00860007326929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown