BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION ID TEST KIT

    MDR report key: 6296044 · Received February 2, 2017

    Report

    Report Number
    1950204-2017-00041
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Report Date
    March 27, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX AN IDENTIFICATION ISSUES WITH STAPHYLOCOCCUS EPIDERMIDIS IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. AN INVESTIGATION WAS CONDUCTED. THE CUSTOMER SUBMITTED FOUR (4) STRAINS AND GP CARDS FROM THE LOT IN QUESTION, ALONG WITH GP CARDS FROM A DIFFERENT LOT THAT WAS PERFORMING AS EXPECTED. ALL FOUR (4) STRAINS WERE TESTED ON THE TWO CARD LOTS RETURNED FROM THE CUSTOMER, RETAINED CARDS OF THE SAME TWO LOTS RETURNED, AND ONE RANDOM LOT. THEREFORE, A TOTAL OF FIVE (5) CARDS WERE TESTED PER ISOLATE. API STAPH WAS ALSO PERFORMED. ISOLATE 911279 (40197056039): FOUR OF THE CARDS TESTED GAVE LOW DISCRIMINATION CALLS OF S. EPIDERMIDIS / S. HOMINIS SSP HOMINIS. THE FIFTH CARD GAVE AN EXCELLENT ID (97%) OF S. EPIDERMIDIS. API STAPH ALSO GAVE A GOOD ID (94.3%) OF S. EPIDERMIDIS. THEREFORE, THE FINAL IDENTIFICATION IS S. EPIDERMIDIS. SINCE THE LOW DISCRIMINATION CALL INCLUDES THE CORRECT CALL OF S. EPIDERMIDIS, ALL CARDS ARE PERFORMING AS EXPECTED. ISOLATE 911280 (40196905288): ON ALL 5 CARDS TESTED, A VERY GOOD ID (95%) OF S. EPIDERMIDIS WAS OBTAINED. API STAPH GAVE A VERY GOOD ID TO THE GENUS OF STAPHYLOCOCCUS: S. EPIDERMIDIS (88.5%) / S. CAPITIS (7%) /S. HAEMOLYTICUS (2%) / S. HOMINIS (2%). ISOLATE 911281 (40197163130): FOUR OF THE CARDS TESTED GAVE VERY GOOD (94%) OR EXCELLENT (96%) ID OF S. WARNERI. ONE CARD GAVE A LOW DISCRIMINATION CALL OF S. WARNERI/S. EPIDERMIDIS/S. HOMINIS SSP HOMINIS. API STAPH GAVE A GOOD ID (94%) OF S. WARNERI. THEREFORE, THE FINAL IDENTIFICATION IS S. WARNERI. SINCE THE LOW DISCRIMINATION CALL INCLUDES THE CORRECT CALL OF S. WARNERI, ALL CARDS ARE PERFORMING AS EXPECTED. ISOLATE 911286 (40196960368): FOUR OF THE CARDS TESTED GAVE AN EXCELLENT ID (99%) OF S. EPIDERMIDIS. ONE CARD GAVE A LOW DISCRIMINATION CALL OF S. EPIDERMIDIS / S. HOMINIS SSP HOMINIS. API STAPH ALSO GAVE A GOOD ID (90.2%) OF S. EPIDERMIDIS. THEREFORE, THE FINAL IDENTIFICATION IS S. EPIDERMIDIS. SINCE THE LOW DISCRIMINATION CALL INCLUDES THE CORRECT CALL OF S. EPIDERMIDIS, ALL CARDS ARE PERFORMING AS EXPECTED. A COMPARISON OF CUSTOMER REACTION RESULTS FOR THE CARDS GIVING THE MISIDENTIFICATION OF S. LUGDUNENSIS AGAINST EXPECTED REACTION RESULTS FOR S. EPIDERMIDIS REVEALED ONE (1) ATYPICAL NEGATIVE REACTION (URE). A COMPARISON OF CUSTOMER REACTION RESULTS FOR THE CARDS GIVING THE MISIDENTIFICATION OF S. HOMINIS SSP HOMINIS AGAINST EXPECTED REACTION RESULTS FOR S. EPIDERMIDIS REVEALED FOUR (4) ATYPICAL NEGATIVE REACTIONS (ADH1, DMAL, BACI, O192R). THE INVESTIGATION CONCLUDED THE VITEK® 2 GP CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX AN IDENTIFICATION ISSUE IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED HAVING MISIDENTIFICATIONS OF STAPHYLOCOCCUS EPIDERMIDIS. THE CUSTOMER STATED THE ORGANISM IS A COAGULASE NEGATIVE STAPHYLOCOCCUS AND MOSTLY STAPHYLOCOCCUS EPIDERMIDIS. THE VITEK® 2 GP ID TEST RESULTS INDICATED MULTIPLE COAGULASE NEGATIVE STAPHYLOCOCCUS SPECIES. THE EXPECTED RESULT WAS STAPHYLOCOCCUS EPIDERMIDIS. THE CUSTOMER TESTED THE SAMPLES USING A MICROSCAN INSTRUMENT AND THE RESULTS WERE STAPHYLOCOCCUS EPIDERMIDIS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN REPORTING RESULTS WHEN SAMPLES ARE RUN ON MICROSCAN, AS THIS TESTING TAKES TWO (2) DAYS TO COMPLETE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THE TEST REPORTS AND ISOLATES WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81865 VITEK® 2 GRAM-POSITIVE IDENTIFICATION ID TEST KIT VITEK® 2 GP ID TEST CARD LQL BIOMERIEUX, INC 2420024103

    Patients

    Seq Age Sex Outcome Treatment
    1