BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 HP RP5700

    MDR report key: 8270883 · Received January 23, 2019

    Report

    Report Number
    1950204-2019-00027
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Report Date
    March 29, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K050002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE CEFOXITIN SCREEN RESULTS ASSOCIATED WITH VITEK® 2 AST-GP67 TEST KIT (REFERENCE# 22226 LOT# 1320879113) WITH SOFTWARE VERSION 7.01. IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX PERFORMED AN INTERNAL INVESTIGATION. THE CUSTOMER DID NOT SUBMIT THEIR ISOLATES OR LAB REPORTS TO BIOMÉRIEUX; THEREFORE, THE CUSTOMER'S TEST DISCREPANCY COULD NOT BE COMPARED TO THE REFERENCE METHOD FOR THIS INVESTIGATION. A REVIEW OF BIOMÉRIEUX MANUFACTURING BATCH RECORDS FOR VITEK® 2 AST-GP67 TEST KIT LOT 1320879113 SHOWED THAT THIS LOT MET ALL FINAL QC RELEASE CRITERIA.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE NEGATIVE CEFOXITIN SCREEN IN ASSOCIATION WITH THE VITEK® 2 HP RP5700. THE CUSTOMER REPORTED THAT THREE STAPHYLOCOCCUS AUREUS ISOLATES COLLECTED FROM DIFFERENT SITES FROM THE SAME PATIENT, WERE TESTED ON VITEK 2 AND GAVE (B)(6) RESULTS. THE BLOOD CULTURE WAS ALSO TESTED ON THE BIOFIRE INSTRUMENT, AND (B)(6) WAS DETECTED. ALL THREE ISOLATES WERE PBP2A POSITIVE. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63454 VITEK® 2 HP RP5700 VITEK® 2 HP RP5700 LON BIOMERIEUX, INC. W0452

    Patients

    Seq Age Sex Outcome Treatment
    1