BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREINER BLOOD CULTURE HOLDER

    MDR report key: 6445797 · Received March 30, 2017

    Report

    Report Number
    3002769706-2017-00059
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JKA
    PMA / PMN Number
    K122687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE CUSTOMERS RECEIVING THIS PRODUCT WERE NOTIFIED THAT THE LABELING IS INCORRECT AND THAT THE PRODUCT IS NOT STERILE AND SHOULD NOT BE USED IN A STERILE ENVIRONMENT. THE SUPPLIER RESPONSIBLE FOR THIS PRODUCT IS IN THE PROCESS OF CORRECTING THE INSTRUCTIONS FOR USE IN MULTIPLE LANGUAGES. BIOMÉRIEUX HAS REMOVED THE INCORRECT IFUS FROM OUR WEBSITE. THE ENGLISH TRANSLATION OF THE INSTRUCTIONS FOR USE IS CORRECT AND STILL PRESENT. THE ROOT CAUSE IS AN INCONSISTENCY BETWEEN THE RECORD TRANSLATIONS.

    Description of Event or Problem · 1

    THE BIOMÉRIEUX ITALY SUBSIDIARY REPORTED AN ERROR IN THE NON-ENGLISH INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH THE GREINER BLOOD CULTURE HOLDER (BIOMÉRIEUX REFERENCE (B)(4), GREINER REFERENCE (B)(4)). THE NON-ENGLISH IFU INDICATE THE GREINER PRODUCT IS STERILE, WHEN IN FACT IT IS NOT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT IFU HAS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE PRODUCT (GREINER BLOOD CULTURE HOLDER, REF. (B)(4)) IS NOT MANUFACTURED BY BIOMÉRIEUX. IT IS MANUFACTURED BY GREINER; HOWEVER, BIOMÉRIEUX PROVIDES IT'S OWN REFERENCE NUMBER AND PRODUCT LABEL. GREINER HAS BEEN NOTIFIED OF THE ISSUE, AND IS TAKING CORRECTIVE ACTION REGARDING THE LABELING ERROR. ENGLISH VERSIONS OF THE PRODUCT LABELING (INSTRUCTION FOR USE) ARE ACCURATE; TRANSLATED IFU CONTAIN THE ERROR. BIOMÉRIEUX HAS REMOVED NON-ENGLISH IFU FROM THE TECHNICAL LIBRARY THAT IS AVAILABLE FOR CUSTOMER USE. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228683 GREINER BLOOD CULTURE HOLDER GREINER BLOOD CULTURE HOLDER JKA BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1