BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST DAPTOMYCIN DPC 256 WW S30

    MDR report key: 10766540 · Received October 30, 2020

    Report

    Report Number
    9615754-2020-00176
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K042392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED AFTER THE CONCLUSION OF AN INVESTIGATION RELATED TO A CUSTOMER COMPLAINT OF FALSE RESISTANT DAPTOMYCIN RESULTS FOR TWO STAPHYLOCOCCUS AUREUS ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-P654 (REF 421912). THE CUSTOMER HAD PERFORMED ETEST® DAPTOMYCIN TESTING AS AN ALTERNATIVE METHOD AND OBTAINED SUSCEPTIBLE RESULTS. THE INTERNAL INVESTIGATION (INV-2454) CONCLUDED THAT THE VITEK 2 RESULTS WERE IN AGREEMENT WITH THE REFERENCE METHOD AND THE CUSTOMER HAD OBTAINED FALSE SUSCEPTIBLE RESULTS IN ASSOCIATION WITH THE ETEST® DAPTOMYCIN DPC 256 WW S30 (REF 412324, LOT 1007622910). THE CUSTOMER'S STRAINS WERE SUBMITTED FOR INVESTIGATIONAL TESTING. BROTH MICRODILUTION (BMD) WAS PERFORMED ON BOTH STRAINS AS THE REFERENCE METHOD AND OBTAINED RESISTANT RESULTS FOR BOTH STRAINS. THE VITEK 2 RESULTS WERE FOUND TO BE IN AGREEMENT WITH THE BMD RESULTS, WHILE THE ETEST RESULTS WERE NOT. PATIENT 1: CUSTOMER INITIAL VITEK 2: DAP MIC = 4 MG/L (RESISTANT). CUSTOMER REPEAT VITEK 2: DAP MIC = 4 MG/L (RESISTANT). CUSTOMER ETEST DAPTOMYCIN: MIC = 1.5 MG/L (SUSCEPTIBLE). INVESTIGATION BMD: DAP MIC = 2 MG/L (RESISTANT). PATIENT 2: INITIAL VITEK 2: DAP MIC = 2 MG/L (RESISTANT). REPEAT VITEK 2: DAP MIC = 4 MG/L (RESISTANT). ETEST DAPTOMYCIN: MIC = 0.75 MG/L (SUSCEPTIBLE). INVESTIGATION BMD: DAP MIC = 2 MG/L (RESISTANT). THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED FOR THE ETEST DISCREPANCY. REF 412324 IS NOT MARKETED OR SOLD IN THE UNITED STATES. THE US VERSION OF THE PRODUCT IS REF 412323 (K042392).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228128 ETEST DAPTOMYCIN DPC 256 WW S30 ETEST® DAPTOMYCIN DPC 256 WW S30 JWY BIOMÉRIEUX SA 1007622910

    Patients

    Seq Age Sex Outcome Treatment
    1