BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® IAST

    MDR report key: 7086436 · Received December 6, 2017

    Report

    Report Number
    3002769706-2017-00397
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Report Date
    February 21, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK020023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION BY A CUSTOMER IN THE UNITED STATES REGARDING A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® IAST (REFERENCE 259786). BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. BACT/ALERT IAST IFU, 9308858 C-2014-11-04 WAS REVIEWED. THE SAMPLE COLLECTION AND VALIDATION SECTION OF THE IFU STATES: "SAMPLES FOR TESTING MAY POSSESS ANTIMICROBIAL PROPERTIES BECAUSE OF THE PRESENCE OF SPECIFIC ANTIMICROBIAL COMPOUND(S) OR BECAUSE OF ITS FORMULATION. THE ANTIMICROBIAL PROPERTY, IF NOT NEUTRALIZED, MAY CAUSE A FALSE NEGATIVE RESULT. PRIOR TO ROUTINE USE, THE USER SHOULD VALIDATE THE SUITABILITY OF THE METHOD FOR EACH SAMPLE TYPE AND VOLUME IN THE BACT/ALERT IAST CULTURE BOTTLES PER THE VALIDATION REQUIREMENTS DESCRIBED IN THE UNITED STATES PHARMACOPEIA (USP) OR EUROPEAN PHARMACOPOEIA (EP)." LIMITATIONS OF THE TEST: "1. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. USERS CONSIDERING THE BACT/ALERT SYSTEM AND CULTURE BOTTLES FOR RELEASE OF MEDICAL PRODUCTS, INCLUDING HUMAN BIOLOGICAL SUBSTANCES, SHOULD FIRST CONSULT THEIR APPROPRIATE REGULATORY AGENCY FOR REQUIREMENTS." PERFORMANCE CHARACTERISTICS OF THE TEST: "STAPHYLOCOCCUS AUREUS NCTC 10788 / ATCC® 6538¿ WITH 20 CFU/BOTTLE AT 32.5 DEGREES C DETECTION TIME IS REPORTED AS 1 DAY." THE GROWTH PERFORMANCE RELEASE TEST IS PERFORMED AT 32.5 +/- 1 DEGREES C. A LOW INOCULUM OF THE ORGANISM AND A LOWER INCUBATION TEMPERATURE CAN RESULT IN VARIABLE RESULTS. THE PERFORMANCE CHARACTERISTICS OF THE TEST IN TABLE 1 OF THE IFU FROM SEEDED STUDIES INCUBATED THE BOTTLES AT 32.5 DEGREES C WITH AN INOCULUM OF 20 CFU PER BOTTLE AND ACHIEVED A DETECTION TIME OF 1 DAY AND 2 DAYS FOR THE USP/EP GROWTH PERFORMANCE TEST. PER BACT/ALERT IAST 9308858 C, THE USER SHOULD VALIDATE SUITABILITY OF THE METHOD FOR EACH SAMPLE TYPE AND VOLUME IN THE BACT/ALERT IAST CULTURE BOTTLES PER THE VALIDATION REQUIREMENTS DESCRIBED IN THE UNITED STATES PHARMACOPEIA (USP) OR EUROPEAN PHARMACOPOEIA (EP). THE BACT/ALERT I AST IFU PROVIDES SUFFICIENT DIRECTION REGARDING THE REQUIREMENT TO VALIDATE THEIR TEST METHOD PER THE VALIDATION REQUIREMENTS DESCRIBED IN THE UNITED STATES PHARMACOPEIA (USP) OR EUROPEAN PHARMACOPOEIA (EP). (30-35 DEGREES C FOR STAPHYLOCOCCUS AUREUS). THE INVESTIGATION CONCLUDED THE ROOT CAUSE OF THE ISSUE REPORTED BY THE CUSTOMER WAS DETERMINED TO BE OFF-LABEL USE (I.E. NOT INCUBATING THE BOTTLES AT A RECOMMENDED TEMPERATURE).

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® IAST (REFERENCE 259786). THE IAST LOTS ARE INDUSTRY SPECIFIC LOTS AND ARE OFTEN USED AT THE USP TEMPERATURE 22.5 C AND EXPECTED TO RECOVERY AEROBIC STAPH AUREUS IN < 5 DAYS. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THE LABORATORY USER OF THIS PRODUCT. THIS PRODUCT IS NOT FOR CLINICAL USE; HOWEVER, THERE IS A SIMILAR PRODUCT THAT IS USED IN A CLINICAL APPLICATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868093 BACT/ALERT® IAST BACT/ALERT® IAST MZC BIOMERIEUX INC. 1048728

    Patients

    Seq Age Sex Outcome Treatment
    1