BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5108666 · Received September 28, 2015

    Report

    Report Number
    1950204-2015-00053
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Report Date
    September 18, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED DUE TO A MISIDENTIFICATION OF THE STRAIN ENTEROCOCCUS FAECIUM BR3 FROM (B)(6) AS THE SPECIES ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK® 2 GP ID CARD. THE FOLLOWING TEST METHODS WERE PERFORMED USING THE (B)(6) SAMPLE: SEQUENCING SODA (REFERENCE METHOD TO DETERMINE THE INTENDED RESULT). VITEK® 2 GP ID CARD (CUSTOMER LOT AND RANDOM LOT). RAPID ID 32 STREP STRIP. API® 20 STREP STRIP. VITEK® MS. RESULTS OF TESTING: SEQUENCING SODA PROVIDED A RESULT TO THE SPECIES ENTEROCOCCUS FAECIUM. VITEK® 2 GP ID PROVIDED RESULTS ON BOTH LOTS (CUSTOMER AND RANDOM) AN EXCELLENT IDENTIFICATION TO ENTEROCOCCUS FAECIUM. RAPID ID 32 STREP: ENTEROCOCCUS FAECIUM. API® 20 STREP: ENTEROCOCCUS FAECIUM. VITEK® MS: ENTEROCOCCUS FAECIUM. THE CUSTOMER RESULTS WERE NOT REPRODUCED. AS THE CUSTOMER DID NOT PROVIDE LAB REPORTS, COMPARISON OF BIOCHEMICAL PROFILES IS NOT POSSIBLE. CARDS ARE PERFORMING AS IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF 21342) WHILE TESTING AN ABP CONTROL ORGANISM (ENTEROCOCCUS FAECIUM). THE CUSTOMER REPORTED ENTEROCOCCUS GALLINARUM. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THE ABP CONTROL SAMPLE WAS NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR WHEN TESTING A PATIENT ISOLATE; THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. THE CUSTOMER NO LONGER HAS THE STRAIN, BUT IS ATTEMPTING TO OBTAIN ANOTHER. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639533 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242341310

    Patients

    Seq Age Sex Outcome Treatment
    1