BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® REVEAL¿ SENSOR PANEL

    MDR report key: 22319365 · Received June 24, 2025

    Report

    Report Number
    1950204-2025-00006
    Event Type
    Malfunction
    Date Received
    June 24, 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. (B)(4)). 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 ¿ ¿NO AST RESULTS¿ ISSUES FOR MULTIPLE ANTIBIOTICS WITH KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. UNKNOWN) IT IS UNDERSTOOD THAT CONDENSATION ISSUES HAS BEEN A REOCCURRING PROBLEM FOR THIS CUSTOMER. IT IS VERY UNUSUAL TO HAVE SUCH A MASSIVE AMOUNT OF CONDENSATION IN THE BEGINNING OF THE RUN AND NONE BY THE END. BIOMÉRIEUX ENGINEER AND GLOBAL CUSTOMER SERVICE ARE THEORIZING THAT IF CUSTOMERS ARE SEALING A COLD SENSOR, IT CREATES A TEMPERATURE GRADIENT THAT WILL CAUSE THE CONDENSATION IN THE BEGINNING OF THE RUN. GCS ASKED THE FOLLOWING QUESTIONS TO LOCAL CUSTOMER SERVICE: ¿ DO YOU KNOW IF THIS CUSTOMER IS REFRIGERATING THE SENSORS? ¿ IF THEY ARE, DO THEY LET IT COME UP TO ROOM TEMPERATURE BEFORE THEY ARE SEALING IT? LOCAL CUSTOMER SERVICE INDICATED THAT: "THE CUSTOMER LETS THE SENSOR WARM UP BEFOREHAND". AT THE TIME OF THE GLOBAL ASSESSMENT, BIOMÉRIEUX GLOBAL CUSTOMER SERVICE DID NOT GET THE DATA FROM THE CUSTOMER TO DETERMINE THE ROOT CAUSE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654250 VITEK® REVEAL¿ SENSOR PANEL VITEK® REVEAL¿ SENSOR PANEL LON BIOMERIEUX, INC. 00860007326929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown