BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SA CULTURE BOTTLE

    MDR report key: 5939098 · Received September 9, 2016

    Report

    Report Number
    3002769706-2016-00165
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Report Date
    August 11, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K020931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED TO BIOMERIEUX A DISCREPANT RESULT EVENT OCCURRED WHEN USING THE BACT/ALERT® SA CULTURE BOTTLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INVESTIGATION EXAMINED THE BACT/ALERT® MANUFACTURING DIRECTIONS, INCLUDING THE ALL IN PROCESS AND FINAL RELEASE INSPECTIONS, AND ALL RESULTS WERE WITHIN ACCEPTANCE CRITERIA. QUALITY CONTROL TESTING WAS ALSO REVIEWED AND MET SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD ON 11APR2016. RETAINED SAMPLES FROM THE LOTS WERE VISUALLY INSPECTED FOR ANY EVIDENCE OF SENSOR DEFECTS. THERE WERE ZERO BOTTLES FOUND TO HAVE SENSOR DEFECTS. AUTOMATED INSPECTION SYSTEMS WERE USED DURING THE PACKAGING OF LOT 1046038, WHICH PERFORMS A 100% INSPECTION OF THE BOTTLE SENSOR COLOR. THE AUTOMATED SYSTEM WILL NOT DIFFERENTIATE THICKNESS OF THE SENSOR IN THE BOTTLE, AS THE SYSTEM IS SETUP TO MEASURE A COLOR SCORE FROM THE BOTTOM OF THE BOTTLE ONLY. LES SLANTS ARE DETECTABLE DEFECTS AND ARE INSPECTED THROUGHOUT THE MANUFACTURING AND PACKAGING PROCESS PER SOP 014798. TWO (2) SLANTS WERE OBSERVED DURING THE POST OVEN INSPECTION, WHICH CONSISTS OF INSPECTING FIFTY (50) BOTTLES, EVERY FIFTEEN (15) MINUTES THROUGHOUT MANUFACTURING FILLING PROCESS. ZERO (0) LES SLANT DEFECTS WERE OBSERVED DURING SUBSEQUENT INSPECTIONS: COMPLETE BOTTLE INSPECTION, RACK/STACK INSPECTION, PACKAGING DEFECT ACTION LOG, AND THE FINAL ACCEPTABLE QUALITY LIMIT (AQL) INSPECTION. THE MOST PROBABLE ROOT CAUSE IN THIS INVESTIGATION WAS THE BOTTLE TIPPED OVER PRIOR TO ENTERING THE OVEN AND WAS INADVERTENTLY SAT UPRIGHT AFTER CURING. REVIEW OF MANUFACTURING RECORDS AND INSPECTIONS INDICATE LES SLANT DEFECTS WERE NOT SYSTEMIC DURING PRODUCTION OF BACT/ALERT® SA LOT 1046038. THE BACT/ALERT® SA IFU WAS REVIEWED AND PROVIDES SUFFICIENT CAUTION TO THE USER THAT, PRIOR TO USE, THE BACT/ALERT® SA CULTURE BOTTLES SHOULD BE EXAMINED FOR EVIDENCE OF DAMAGE OR DETERIORATION (DISCOLORATION). BOTTLES EXHIBITING EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION SHOULD BE DISCARDED. THE INSTRUCTIONS FOR USE SHOULD BE CLOSELY ADHERED TO IN ORDER TO AVOID INOCULATING BOTTLES WITH SENSOR DEFECTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BIOMERIEUX A DISCREPANT RESULT EVENT OCCURRED WHEN USING THE BACT/ALERT SA CULTURE BOTTLE. THE CUSTOMER REPORTED THAT THE BACT/ALERT SA CULTURE BOTTLE RETURNED A (B)(4) RESULT FOR A PATIENT SAMPLE. UPON REMOVING THE BOTTLE FROM THE INSTRUMENT, THE LABORATORY TECHNICIAN NOTICED THAT ONLY A PORTION OF THE BOTTOM OF THE BOTTLE HAD THE LES SENSOR PRESENT. A PREVIOUSLY COLLECTED SAMPLE INOCULATED INTO ANOTHER BACT/ALERT SA CULTURE BOTTLE FLAGGED (B)(6) AND A SUBSEQUENT SUBCULTURE OF THAT BOTTLE WAS (B)(6). WHEN SPECIFICALLY ASKED, THE CUSTOMER INDICATED NO ADVERSE IMPACT TO THE PATIENT OR DELAY IN RESULTS WAS EXPERIENCED AS A RESULT OF THIS EVENT. AN INVESTIGATION WILL BE INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591772 BACT/ALERT® SA CULTURE BOTTLE BACT/ALERT® SA CULTURE BOTTLE MDB BIOMERIEUX, INC 1046038

    Patients

    Seq Age Sex Outcome Treatment
    1