BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® IAST

    MDR report key: 7007002 · Received November 7, 2017

    Report

    Report Number
    3002769706-2017-00330
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Report Date
    December 1, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK020023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE INVESTIGATION EXAMINED THE BOTTLE RETAIN SAMPLES AND BACT/ALERT I AST BOTTLE MANUFACTURING RECORDS. THE REVIEW FOUND ALL THE SPECIFICATIONS WERE MET. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOT FOR DISTRIBUTION. A HISTORICAL REVIEW OF THE COMPLAINTS FOUND NO TREND RELATED TO BOTTLE LOT. THE GROWTH PERFORMANCE RELEASE TEST IS PERFORMED AT 32.5 +/- 1 DEGREES C. A LOW INOCULUM OF THE ORGANISM AND A COOLER 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).

    Description of Event or Problem · 1

    A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® IAST (REFERENCE 259786). THE CUSTOMER REPORTED THAT THE BOTTLES DID NOT PASS THE GROWTH PROMOTION TEST. STAPHYLOCOCCUS AUREUS (BIOBALL REF. 56045) DID NOT GROW WITHIN SEVEN ( 7) DAYS (ACCORDING TO THE EP). THE CUSTOMER TESTED TWO BOTTLES: BIOBALL BATCH 3787 - DAYS UNTIL NO DETECTION: NO GROWTH (9.1 DAYS), BIOBALL BATCH 3787 - DAYS UNTIL DETECTION: NO GROWTH (10 DAYS). THE CUSTOMER COULD NOT USE THE LOT. 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
    786253 BACT/ALERT® IAST BACT/ALERT® IAST MZC BIOMERIEUX INC. 1047747

    Patients

    Seq Age Sex Outcome Treatment
    1