BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5998388 · Received October 4, 2016

    Report

    Report Number
    1950204-2016-00142
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    September 6, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ATCC® BAA-750¿ STAPHYLOCOCCUS SAPROPHYTICUS AS AEROCOCCUS VIRIDANS OR STAPHYLOCOCCUS LENTUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE SUBMITTED CUSTOMER'S QC STRAIN AND THE IN-HOUSE QC STRAIN WERE SUBCULTURED AND TESTED ON TWO (2) CARDS FROM TWO (2) GP CARD LOTS. THE LOT NUMBER TESTED BY THE CUSTOMER, 2420015103, WAS NOT AVAILABLE IN STORAGE. THE EIGHT (8) CARDS TESTED ON THESE STRAINS ALL GAVE THE EXPECTED NEGATIVE AMY, DRAF, AND DSOR REACTIONS. THE CUSTOMER DID NOT SUBMIT ARCHIVED DATA SO IT WAS NOT POSSIBLE TO DETERMINE WHAT MAY HAVE CAUSED THE QC DEVIATION. VITEK® 2 GP CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF ATCC BAA-750STAPHYLOCOCCUS SAPROPHYTICUS AS AEROCOCCUS VIRIDANS OR STAPHYLOCOCCUS LENTUS IN ASSOCIATION WITH THE VITEK 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. REPEAT TEST OBTAINED THE SAME RESULT. WHEN ASKED ABOUT THEIR PREPARATION PROCESS FOR THE QC ORGANISM, THE CUSTOMER STATED THEY PURCHASE A STRAIN AND SUB-CULTURE IT TO A MEDIA PLATE. AFTER ONE WEEK, THEY USE THE ORGANISM GROWTH ON THIS PLATE TO SUB-CULTURE A SECOND PLATE. THIS IS REPEATED A THIRD TIME; THEY PERFORM TESTING FROM THE ORGANISM GROWTH ON THIS THIRD PLATE. THIS METHOD DEVIATES FROM THAT IN THE INSTRUCTIONS FOR USE (IFU). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE ATCC STRAIN. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648003 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 2420015103

    Patients

    Seq Age Sex Outcome Treatment
    1