BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT SA (PLASTIC)

    MDR report key: 6174038 · Received December 14, 2016

    Report

    Report Number
    3002769706-2016-00516
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 22, 2016
    Report Date
    March 7, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K020931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED FOR A DUPLICATE BOTTLE IDENTIFICATION (ID) NUMBER WHILE UTILIZING A BACT/ALERT® SA (PLASTIC) CULTURE BOTTLE. THE INVESTIGATION EXAMINED THE BACT/ALERT® MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS WERE WITHIN SPECIFICATION. A REVIEW OF THE LOT FOUND NO CAUSE FOR THE EVENT TO BE CAUSED BY LABEL DUPLICATION. BASED UPON THE CUSTOMER INTERACTION, BIOMÉRIEUX IDENTIFIED THE PROBABLE ROOT CAUSE AS USER ERROR. THE CUSTOMER WAS HAVING ISSUES SCANNING THE BOTTLE AND MANUALLY TYPED THE BOTTLE ID INCORRECTLY. WHEN THE ID WAS MANUALLY TYPED, IT WAS TYPED IN AS A PREVIOUSLY UNLOADED BOTTLE ID. IT IS POSSIBLE FOR THE BOTTLE ID TO ONLY BE ONE CHARACTER DIFFERENT IN THE SAME SHIPMENT. AS SUCH, THE ERROR CODE "945" WAS RECEIVED. THE INVESTIGATION CONCLUDED THE BACT/ALERT® SA (PLASTIC) CULTURE BOTTLES PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN ISSUE ASSOCIATED WITH THE BACT/ALERT® SA (PLASTIC) CULTURE BOTTLES. THE CUSTOMER REPORTED THAT WHILE UNLOADING A NEGATIVE BATCH, A BOTTLE ID , THAT WAS NEGATIVE DAYS AGO, WAS NOW LINKED TO A NEW PATIENT ACCORDING TO OBSERVA®. THE CUSTOMER NOTICED THAT ON (B)(6) 2016 AROUND 1300 AS THEY WERE LOADING A NEW SET OF BACT/ALERT® SA AND BACT/ALERT® SN CULTURE BOTTLES FOR A PATIENT, WHEN THEY SCANNED THE SA BOTTLE, THEY GOT AN ERROR 945 (BOTTLE ID ENTERED MATCHES THAT OF A PREVIOUSLY UNLOADED BOTTLE). SO INSTEAD OF ATTENDING TO IT RIGHT AWAY, THE BOTTLE WAS SCANNED WITH THE ACCESSION NUMBER INSTEAD. ABOUT TWO (2) HOURS LATER, A LABORATORY TECHNICIAN TRIED TO FIX THE ISSUE BY CHANGING THE BOTTLE ID TO THE CORRECT ONE THAT WAS ON THE BOTTLE; HOWEVER, A 945 ERROR WAS OBTAINED AGAIN. THE LABORATORY TECHNICIAN DID A SEARCH OF THE BOTTLE ID (THAT GAVE THE 945 ERROR) AND DETERMINED THAT THE BOTTLE BELONGED TO ANOTHER PATIENT THAT WAS LOADED ON (B)(6) 2016 AND FINALIZED AS NEGATIVE ON (B)(6) 2016. THE BOTTLE/SENSOR FOR THE CURRENT BOTTLE WAS INSPECTED AND THE CUSTOMER WAS PROVIDED INSTRUCTIONS FOR RELOADING THE BOTTLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824657 BACT/ALERT SA (PLASTIC) BACT/ALERT SA (PLASTIC) MDB BIOMERIEUX, INC 3046394

    Patients

    Seq Age Sex Outcome Treatment
    1