BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002769706-2017-00058

    MDR report key: 6445791 · Received March 30, 2017

    Report

    Report Number
    3002769706-2017-00058
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Report Date
    March 9, 2018
    PMA / PMN Number
    K122687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THIS INVESTIGATION WAS INITIATED DUE TO A TRANSLATION ERROR IN THE (B)(6) VERSION OF THE INSTRUCTIONS FOR USE (IFU): THE DEVICE IS MENTIONED AS STERILE WHILE IT IS A NON-STERILE DEVICE. AN INTERNAL NONCONFORMING MATERIAL REPORT (NCMR) HAS BEEN OPENED BY BIOMÉRIEUX (B)(4) TO SOLVED THE TRANSLATION ISSUES. USERS OF THESE PRODUCTS HAVE BEEN ADVISED OF THE ERROR. SOME MEETINGS HAVE BEEN ORGANIZED WITH THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) TO DEFINE THE CORRECTIVE ACTION PLAN. CORRECTION OF THE IFU TO MODIFY THE STERILE / NON-STERILE ERROR ON THE OEM'S WEBSITE.

    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 413200, GREINER REFERENCE 980236). 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. 413200) 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.

    Patients

    Seq Age Sex Outcome Treatment
    1