BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GP TEST KIT

    MDR report key: 6145431 · Received December 5, 2016

    Report

    Report Number
    1950204-2016-00196
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF AN ORGANISM STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS INTERMEDIUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT INVOLVING A PATIENT SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THREE (3) GRAM POSITIVE ISOLATES WERE SUBMITTED FOR VITEK® 2 GP CARD EVALUATION BECAUSE THE GP CARDS IDENTIFIED ONE (1) ISOLATE (27498) AS STAPHYLOCOCCUS HAEMOLYTICUS AND THE OTHER TWO (2) ISOLATES (283015 AND 277389) AS STAPHYLOCOCCUS INTERMEDIUS. HOWEVER, UPON REPEAT TESTING, ALL THREE (3) ISOLATES WERE IDENTIFIED AS S. AUREUS. IN ADDITION, ALL THREE (3) WERE STAPHAUREX POSITIVE, AND ONE (1) ISOLATE WAS ALSO IDENTIFIED AS S. AUREUS USING BIOFIRE®. ARCHIVED DATA WAS SUBMITTED BY THE CUSTOMER. ALL THREE (3) STRAINS WERE SUBCULTURED, AND TESTING INCLUDED THE CUSTOMER LOT AND A RANDOM LOT OF VITEK® 2 GP CARDS. API® STAPH WAS ALSO PERFORMED. ISOLATE 911240 (279498): EXCELLENT IDS OF S. AUREUS WERE OBTAINED FOR BOTH CARDS TESTED. THE API® STAPH GAVE A GOOD ID (97.7%) OF S. AUREUS. THEREFORE, THE FINAL IDENTIFICATION IS S. AUREUS. WHEN COMPARED TO THE EXPECTED REACTION RESULTS FOR S. AUREUS, THE CUSTOMER CARD GIVING THE S. HAEMOLYTICUS CALL HAD ONE (1) ATYPICAL POSITIVE REACTION ( DGAL) AND FOUR (4) ATYPICAL NEGATIVE REACTIONS (AGLU, PHOS, NAG, MBDG), WHICH LED TO THE MISIDENTIFICATION. AN EXAMINATION OF INTEGRATED CARD DATA FROM THE CUSTOMER SHOWED THAT THE REACTIONS APPEARED WEAKER AND DELAYED IN THE CARD GIVING THE S. HAEMOLYTICUS CALL. ISOLATE 911241(283015): EXCELLENT IDS OF S. AUREUS WERE OBTAINED ON BOTH CARDS TESTED. API® ALSO GAVE A GOOD ID (94%) OF S. AUREUS, SO THE FINAL IDENTIFICATION IS S. AUREUS. A COMPARISON OF REACTION RESULTS FOR THE CUSTOMER CARD GIVING THE S. INTERMEDIUS IDENTIFICATION AGAINST THE EXPECTED REACTION RESULTS FOR S. AUREUS REVEALED ONE (1) ATYPICAL POSITIVE REACTION (URE). GRAPHICAL REVIEW OF THE GROWTH CURVES SHOWED A STRONG EARLY REACTION FOR THE URE WELL FOR THE CARD. ALL OTHER WELLS SHOWED DELAYED REACTION WHEN COMPARED TO THE CARD THAT GAVE THE S. AUREUS IDENTIFICATION. ISOLATE 911242(277389): EXCELLENT IDS OF S. AUREUS WERE OBTAINED ON BOTH CARDS TESTED. API® ALSO GAVE A GOOD ID (94%) OF S. AUREUS, SO THE FINAL IDENTIFICATION IS S. AUREUS. A COMPARISON OF REACTION RESULTS FOR THE CUSTOMER CARD GIVING THE S. INTERMEDIUS IDENTIFICATION AGAINST THE EXPECTED REACTION RESULTS FOR S. AUREUS REVEALED ONE (1) ATYPICAL POSITIVE REACTION (URE) AND TWO (2) ATYPICAL NEGATIVE REACTIONS (AGLU, DMNE), WHICH LED TO THE MISIDENTIFICATION. GRAPHICAL REVIEW COULD NOT BE PERFORMED, AS ONLY THE RAW DATA FOR THE CARD GIVING THE S. AUREUS CALL WAS PRESENT. FOR ALL INTEGRATED DATA, IT IS NOT CLEAR WHAT THE CAUSE OF THE DELAYED AND/OR WEAKER REACTIONS MAY BE. VITEK® 2 GP ID CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF AN ORGANISM STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS HAEMOLYTICUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT INVOLVING A PATIENT KNEE SAMPLE. THE MISIDENTIFICATION OF THE ORGANISM DID NOT IMPACT THE PATIENT AND THERE WAS NO DELAY IN PATIENT TREATMENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796309 VITEK 2 GP TEST KIT VITEK 2 GP TEST KIT LQL BIOMERIEUX, INC 2420092103

    Patients

    Seq Age Sex Outcome Treatment
    1