BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC MGIT

    MDR report key: 3415594 · Received September 6, 2013

    Report

    Report Number
    1119779-2013-00009
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MDB
    PMA / PMN Number
    K974883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD QUALITY DETERMINED THAT LOT 3042467 WAS REWORKED DUE TO AN INCORRECT BARCODE LABEL AND HAD AN OVER-LABEL MANUALLY APPLIED TO EACH TUBE. BD QUALITY INSPECTED REMAINING OVER-LABELED PRODUCT AND FOUND THAT TUBES HAD VARYING DEGREES OF PEELING OCCURRING AROUND THE EDGES OF THE LABEL. THE ADHESIVE IN THE CENTER OF THE LABEL WAS PROPERLY ADHERED AND REQUIRED SOME FORCE TO REMOVE. NO TUBES WERE FOUND WITH DOUBLE LABELS OR WITHOUT AN OVER-LABEL DURING THE INSPECTION. OBSERVATION OF THESE SAMPLES INDICATES THAT THE MANUAL APPLICATION OF THE OVER-LABEL MAY NOT HAVE PROVIDED PRESSURE OVER THE ENTIRE LABEL SURFACE, ALLOWING THE EDGES TO LIFT FROM THE TUBE. AN ENGINEERING STUDY WAS CONDUCTED DURING THE INITIAL INVESTIGATION WHICH TESTED ADHESIVE PROPERTIES OF THE OVER-LABEL. TESTING SHOWED SATISFACTORY RESULTS FOR EXPOSURE TO TEMPERATURES RANGING FROM 0 DEGREES FAHRENHEIT TO 120 DEGREES FAHRENHEIT FOR A PERIOD OF 96 HOURS. BD QUALITY WAS UNABLE TO DETERMINE BASED ON CUSTOMER RETURNS AN PHOTOGRAPHS IF THE OVER-LABEL BARCODE WAS REMOVED BY THE CUSTOMER PRIOR TO SCANNING THE BARCODE AND ATTEMPTING TO PLACE INTO THE MGIT INSTRUMENT. CORRECTIVE ACTIONS: REWORK PROCEDURE WILL BE MODIFIED TO UPDATE QUALITY PLAN / AQL LEVEL INSPECTION REQUIREMENTS, MAINTENANCE OF REWORK INSTRUCTIONS, AND TRAINING REQUIREMENTS. BD IS INITIATING A RECALL ON MONDAY 09/09/2013 TO INFORM CUSTOMERS OF THE RELABEL PROCESS. BD WILL REPORT THIS RECALL TO THE FDA WITHIN 10 DAYS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED AN INTERFACE ERROR ON BD EPICENTER DATA MGMT SYS DURING VITAL ENTRY ON THEIR BACTEC MGIT 960 INSTRUMENT. THE BD EPICENTER DETECTED AN INCORRECT BARCODE (B)(4) TERMINATING COMMUNICATION WITH THE BD MGIT 960 INSTRUMENT AND INSTRUCTED THE USER TO CONTACT THEIR BD TECHNICAL REP FOR ASSISTANCE. CUSTOMER EXAMINED LOT AND DETERMINED THAT TUBES HAD BEEN OVER-LABELED WITH BARCODE (B)(4). CUSTOMER NOTED SOME OVER-LABELS WERE CROOKED, PEELING, DOUBLE LABELED OR MISSING. THE 3RD AND 4TH DIGITS OF THE BARCODE INDICATE THE MEDIA TYPE AND WHICH ALGORITHM TO APPLY FOR GROWTH DETECTION. IF THE ISSUE GOES UNRECOGNIZED, BARCODES WITH A PREFIX "43 02" INCUBATE FOR THE DESIRED PROTOCOL BUT REPORT ALL TUBES AS NEGATIVE SINCE NO ALGORITHM IS APPLIED. THE BACTEC MGIT TUBE PACKAGE INSERT RECOMMENDS: "AT THE END OF SIX WEEKS INCUBATION, PERFORM A VISUAL CHECK OF ALL INSTRUMENT NEGATIVE TUBES. IF THE TUBE APPEARS VISUALLY POSITIVE (I.E., NONHOMOGENOUS, TURBIDITY, SMALL GRAINS OT CLUMPS) IT SHOULD BE SUBCULTURED, ACID-FAST STAINED AND TREATED AS A PRESUMPTIVE POSITIVE, PROVIDED THE ACID-FAST SMEAR RESULT IS POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445168 BACTEC MGIT MDB BD DIAGNOSTIC SYSTEMS 3040436

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention