BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS

    MDR report key: 13537242 · Received February 15, 2022

    Report

    Report Number
    3002769706-2022-00015
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF A FALSE POSITIVE RESULT (POSSIBLE CONTAMINATION) OF A BLOOD CULTURE BOTTLE WHILE TESTING A PATIENT SAMPLE WITH THE BACT/ALERT® FA PLUS (REF 410851, LOT 0004100564). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS. NO ADVERSE TREND IS PRESENT IN THE COMPLAINT DATA FOR THE LOT NUMBERS, ORGANISM, OR ERROR CODE. MANUFACTURING DIRECTIONS (MD) REVIEW: A REVIEW OF THE MANUFACTURING DIRECTIONS (MD) FOR FINISHED GOODS BACT/ALERT FA PLUS LOT 0004100564 WAS PERFORMED BY THE INVESTIGATOR ON 21SEP2022. THE CHEMWEIGH, FORMULATION, FILLING, AND PACKAGING MD WERE REVIEWED. THERE WERE NO BIOBURDEN RESULTS OUT OF SPECIFICATION. THERE WERE NO ANOMALIES DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THE ROOT CAUSE OF THIS EVENT. COMPLETE BOTTLE INSPECTION, PACKAGING AQL INSPECTION, AND FINAL AQL INSPECTION WERE ALSO REVIEWED AND NO DEFECTS RELATED TO THIS EVENT WERE DISCOVERED DURING INSPECTIONS. THERE WERE ZERO BOTTLES FOUND WITH TURBIDITY. ALL THE QUALITY RELEASE TEST RESULTS WERE CONFORMING AND ALL IN-PROCESS STATISTICAL PROCESS CONTROLS WERE WITHIN REQUIREMENTS. THE REPORT ¿CPV-21-0107 CONTINUOUS PROCESS VERIFICATION REPORT FOR BACT/ALERT MANUFACTURING ON PRODUCTION LINE 4, MONITORING PERIOD 01JAN21 THROUGH 31DEC21¿ WAS REVIEWED BY THE INVESTIGATOR AS IT CONTAINS DATA FOR THE FILLING LOT 4100563 THAT IS RELATED TO THE RELEASE LOT 0004100564 FOR THIS INVESTIGATION. THE RELEASE C BIOBURDEN DATA WAS REVIEWED AND FOUND TO BE IN CONTROL WITH NO FURTHER ANALYSIS OR ACTION REQUIRED. NO MANUFACTURING CAPA OR DEVIATIONS WERE DOCUMENTED THAT RELATE TO THIS INVESTIGATION. THE LOT MET ALL QUALITY FINISHED GOODS RELEASE CRITERIA. QUALITY APPROVED THE RELEASE OF 10,695 CASES OF BACT/ALERT FA PLUS LOT 0004100564 ON 17DEC2021. THE BOTTLE LOT CERTIFICATE OF CONFORMANCE STATES ¿NO EVIDENCE OF CONTAMINATION¿. RETAIN SAMPLES: THERE WERE 300 FINISHED GOOD RETAINED BOTTLES FOR LOT 0004100564 INSPECTED BY MANUFACTURING'S QUALITY FLOOR SUPPORT ON 27APR2022. NO CLOUDY BOTTLES, OR BOTTLES WITH YELLOW SENSORS WERE DISCOVERED. INSTRUCTIONS FOR USE (IFU) REVIEW: A REVIEW OF THE BACT/ALERT® FA PLUS (PART NUMBER 410851) INSTRUCTIONS FOR USE (DOCUMENT 043784- 03 - 2020-02) SHOWS THAT IT PROVIDED ADEQUATE GUIDANCE TO THE USER TO AVOID CONTAMINATION OF THE BOTTLE DURING INOCULATION. THE IFU ALSO STATES TO EXAMINE BOTTLES FOR SIGNS OF CONTAMINATION BEFORE USE. NO REVISIONS ARE NEEDED. ROOT CAUSE: THE FIVE WHYS ROOT CAUSE ANALYSIS TOOL WAS USED TO ASSESS THIS COMPLAINT. STREPTOCOCCUS OVIS IS NOT A COMMON ISOLATE IN THE CLINICAL LABORATORY. THIS ORGANISM IS ALPHA-HEMOLYTIC SIMILAR TO OTHER STREPTOCOCCI SPECIES FOUND IN ORAL NORMAL FLORA. SOME STREPTOCOCCUS SPECIES (BETA-HEMOLYTIC FOR EXAMPLE) CAN BE ASSOCIATED WITH NOSE/THROAT INFECTIONS, ABSCESSES, OR WOUND/SORES ON SKIN. THESE ROOT CAUSES WERE NOT AS LIKELY: ANOTHER DEVICE OR PRODUCT USED IN THE BLOOD COLLECTION CONTAINED THE CONTAMINANT. ANOTHER DEVICE OR PRODUCT USED ON/FOR THE PATIENT CONTAINED THE CONTAMINANT. ENVIRONMENTAL CONTAMINATION ¿ ONLY ONE BOTTLE WAS REPORTED, AND S. OVIS IS NOT A COMMON ENVIRONMENTAL ORGANISM. THE BOTTLE ALREADY CONTAINS THE ORGANISM ¿ NOTHING FOUND TO SUPPORT THIS SOURCE IN THE INVESTIGATION. THESE ROOT CAUSES WERE MORE LIKELY: BOTTLE¿S STOPPER OR VENIPUNCTURE SITE WERE NOT CLEANED, OR NOT CLEANED ADEQUATELY ¿ CUSTOMER¿S PROCEDURE TO DRAW BLOOD INTO TEST TUBE AND THEN TRANSFER TO BOTTLE INCREASES RISK OF CONTAMINATION. PATIENT¿S SAMPLE REALLY DID CONTAIN THE ORGANISM. ---CONCLUSION--- THE INVESTIGATION DID NOT IDENTIFY ANY PERFORMANCE ISSUE WITH THE PRODUCT AND THERE IS NO EVIDENCE THAT THE BOTTLE WAS CONTAMINATED PRIOR TO USE BY THE CUSTOMER. LIKELY CAUSES FOR THE POSITIVE RESULTS WERE DETERMINED TO BE DUE TO USER ERROR OR THE PATIENT'S SAMPLE ACTUALLY DID CONTAIN THE ORGANISM.

    Description of Event or Problem · 0

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT (POSSIBLE CONTAMINATION) OF A BLOOD CULTURE BOTTLE WHILE TESTING A PATIENT SAMPLE WITH THE BACT/ALERT® FA PLUS (REF 410851, LOT 0004100564). THE CUSTOMER INQUIRED IF OTHER CUSTOMERS HAD OBSERVED STREPTOCOCCUS OVIS IN THEIR BOTTLES AFTER ONE BOTTLE GREW STREPTOCOCCUS OVIS. FOUR (4) BOTTLES WERE TESTED FOR THIS PATIENT AND ONE GREW STREPTOCOCCUS OVIS. THE OTHERS DID NOT INDICATE GROWTH OF ANY BACTERIA. THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE GROWTH OF STREPTOCOCCUS OVIS WAS NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER ALSO REPORTED THAT THE PATIENT DID NOT HAVE A FEVER OR ELEVATED WHITE BLOOD CELL COUNTS. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843903 BACT/ALERT® FA PLUS BACT/ALERT® FA PLUS MDB BIOMÉRIEUX, INC. 0004100564 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown