BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVI® COLOR GRAM V2

    MDR report key: 6033756 · Received October 17, 2016

    Report

    Report Number
    3002769706-2016-00446
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Report Date
    September 19, 2016
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 28NOV2016. THE CUSTOMER CLARIFIED THAT THEY DO NOT HAVE A BIOMÉRIEUX PREVI® COLOR GRAM AND WERE TOLD TO CONTACT BIOMÉRIEUX IN ERROR. THE CUSTOMER INDICATED HAVING A WESCOR ELITECH AEROSPRAY AND CONFIRMED MAKING CONTACT WITH WESCOR. THEREFORE, THIS EVENT IS NOT REPORTABLE IN REGARD TO THE BIOMÉRIEUX PREVI® COLOR GRAM.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT GRAM STAIN RESULT FOR CAP SURVEY (GRAM POSITIVE INSTEAD OF GRAM NEGATIVE DIPLOCOCCUS) IN ASSOCIATION WITH THE PREVI® COLOR V2 INSTRUMENT. REPEAT TESTING PROVIDED THE SAME DISCREPANT RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT GRAM STAIN RESULT IMPACTED ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CAP SURVEY SAMPLE. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686020 PREVI® COLOR GRAM V2 PREVI® COLOR GRAM KPA BIOMERIEUX, SA 414292

    Patients

    Seq Age Sex Outcome Treatment
    1