BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5081564 · Received September 16, 2015

    Report

    Report Number
    1950204-2015-00034
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Report Date
    September 11, 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

    INTERNAL INVESTIGATION WAS CONDUCTED. THE ORGANISM WAS SUB-CULTURED, AND TESTING INCLUDED: VITEK® 2 GP ID CARD. 16S SEQUENCING (REFERENCE METHOD) TO DETERMINE THE INTENDED RESULT. RESULTS: 16S SEQUENCING CONFIRMED THE EXPECTED IDENTIFICATION TO SPECIES ACTINOBACULUM SCHAALII. VITEK® 2 GP ID PROVIDED AN IDENTIFICATION TO SPECIES GRANULICATELLA ADJACENS. THE CUSTOMER RESULT OF E. CASSELIFLAVUS WAS NOT DUPLICATED. CLINICAL INFORMATION ASSOCIATED WITH THE SURVEY SAMPLE FROM ANSM: MR X (B)(6) YEARS OLD, WITH A PROSTATE CANCER HISTORY, HAS ALL THE SIGNS OF INFECTION MALE URINARY. NOTE THAT THE PATIENT HAS NO BLADDER CATHETER. A URINE CULTURE IS DONE WITH DIRECT EXAMINATION AND SHOWS THE PRESENCE OF MANY GRAM POSITIVE BACTERIA AND A LEUKOCYTURIA SUPERIOR TO 105 / ML. BLOOD AGAR CULTURE SHOWS A BACTERIUM IN A LARGE QUANTITY (106 CFU / ML) AFTER 48 HOURS OF INCUBATION IN ANAEROBIOSIS AT 35 ° C. CAUTION: POSSIBLE DISSOCIATION OF THE LYOPHILIZED STRAIN WITH THE PRESENCE OF TWO DIFFERENT TYPES OF MORPHOLOGY OF COLONIES. THE ABOVE STATEMENT FROM ANSM CLEARLY INDICATES THE SAMPLE SHOULD BE INCUBATED ANAEROBICALLY. THIS IMPLIES ANAEROBIC TESTING. IN THE GP ID CULTURE REQUIREMENT TABLE, THE INCUBATION CONDITIONS ARE 35°C TO 37°C, 5% TO 10% CO2 OR AEROBIC, NON-CO2. THE GP ID IS NOT AN APPROPRIATE SELECTION FOR THIS SURVEY SAMPLE. FOR ANAEROBIC STRAIN, AS INDICATED IN CLINICAL INFORMATION FROM ANSM, THE CARD VITEK2 REQUIRED IS ANC. ACTINOBACULUM SCHAALII IS NOT CLAIMED IN THE VITEK® 2 SYSTEMS GP ID KNOWLEDGE BASE. THE VITEK® 2 PRODUCT INFORMATION MANUAL (B)(4) INDICATES WHICH ORGANISMS CAN BE IDENTIFIED USING THE VITEK® 2 GP ID CARD; ACTINOBACULUM SCHAALII IS NOT LISTED. PER THE VITEK® 2 PRODUCT INFORMATION MANUAL, "TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR MISIDENTIFICATION." FOR ANY ORGANISM PLACED INTO A TEST CARD, THE VITEK® 2 SYSTEM WILL ASSESS THE CARD READINGS AGAINST THE KNOWN ORGANISMS AND PROVIDE AN ORGANISM IDENTIFICATION, IF POSSIBLE, BASED ON A COMBINATION OF GROWTH WELL REACTIONS. FOR RESULTS WITH A PERCENT CONFIDENCE OF <99%, THE CUSTOMER MUST MAKE A DETERMINATION OF ACCEPTANCE OR FURTHER TESTING BASED ON THE LOGICAL LIKELIHOOD OF THE IDENTIFICATION CONSIDERING OTHER LABORATORY AND CLINICAL FACTORS. THE VITEK® 2 GP ID CARD IS PERFORMING AS INTENDED WITHIN THE SCOPE OF PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF AN (B)(4) PROFICIENCY SPECIMEN (ACTINOBACULUM SHAALII) AS ENTEROCOCCUS CASSELIFLAVUS IN ASSOCIATION WITH THE VITEK 2 GP ID CARD. 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. NO PATIENT WAS DIRECTLY ASSOCIATED WITH THE (B)(4) PROFICIENCY RESULT. 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. PROFICIENCY ORGANISM SUBMITTAL HAS BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612872 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1