BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENSICHEK PLUS

    MDR report key: 11041589 · Received December 18, 2020

    Report

    Report Number
    1950204-2020-00217
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    March 22, 2021
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026222239
    PMA / PMN Number
    K083536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING A FLUCTUATION IN THE TURBIDITY READING WHILE USING THE DENSICHECK® PLUS INSTRUMENT (REFERENCE # 21250, SERIAL # (B)(4)). THE TURBIDITY (OPTICAL DENSITY) IS EXPRESSED IN UNITS OF MCFARLANDS (MCF). THE CUSTOMER REPORTED THIS EVENT TO THE (B)(6) NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE CUSTOMER IS CURRENTLY UTILIZING THE DENSICHEK PLUS INSTRUMENT. THE CUSTOMER¿S CASE REPORT STATES: ¿FOR THE DENSICHEK PLUS INSTRUMENT, THE CONCERNING UNIT IS INSTALLED AT (B)(6), 2014, WITH SERIAL NO. AS (B)(4), WE USE A BOX OF STANDARD KIT WITHIN EXPIRY LIMIT TO PERFORM VERIFICATION WITH REFER TO STANDARD OPERATION PROCEDURE BY VORTEX THE TUBE, SET THE MATERIAL TO GLASS, LOAD THE BOTTLE AND PERFORM READING, BUT WE FIND THE READ VALUE FLUCTUATES AND MAKE THE TEST RESULT UNRELIABLE.¿ IT WAS DETERMINED THAT VORTEX MIXING OF THE STANDARDS WAS THE ROOT CAUSE. VORTEX MIXING IS CONSIDERED OFF-LABEL USE, AS A VORTEX MIXER IS SIMILAR TO SHAKING THE STANDARDS. THE DENSICHEK® PLUS INSTRUMENT USER MANUAL (PN 24384) & THE 21255 STANDARD PACKAGE INSERT (PN 043395) STATES ¿2. GENTLY INVERT THE 0.0 MCF STANDARD FIVE TO SIX TIMES TO ENSURE IT IS HOMOGENEOUS¿ AND ¿5.0 GENTLY INVERT THE STANDARD FIVE TO SIX TIMES TO ENSURE IT IS HOMOGENEOUS¿. THE CAUTION/WARNINGS AND PRECAUTION STATES ¿DO NOT SHAKE THE STANDARD. AIR BUBBLES WILL AFFECT READINGS¿.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FLUCTUATION IN THE TURBIDITY READING WHILE USING THE DENSICHECK ® PLUS INSTRUMENT (REFERENCE # 21250, SERIAL # (B)(4)). THE TURBIDITY (OPTICAL DENSITY) IS EXPRESSED IN UNITS OF MCFARLANDS (MCF). THIS ISSUE OCCURRED WHILE THE CUSTOMER PERFORMED MAINTENANCE INSTRUMENT VERIFICATION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER HAS BEEN USING THIS INSTRUMENT SINCE 2014. THEY WERE PERFORMING MAINTENANCE INSTRUMENT VERIFICATION WITH A STANDARD KIT THAT WAS WITHIN EXPIRY WHEN THEY NOTICED THE READ VALUE FLUCTUATING. A FIELD SERVICE EXPERT (FSE) WENT TO THE CUSTOMER SITE TO CHANGE THE BATTERIES IN THE INSTRUMENT, PERFORM CLEANING OF THE TUBE INSERT AND REPLACE THE STANDARD KIT WITH A NEW ONE BUT THE ISSUE STILL OCCURRED. IT WAS RECOMMENDED THAT THE CUSTOMER REPLACE THEIR EXISTING INSTRUMENT. DENSICHEK® PLUS IS INTENDED FOR USE WITH THE VITEK® AND VITEK® 2 SYSTEMS TO MEASURE THE OPTICAL DENSITY OF A MICROORGANISM SUSPENSION. THIS MICROORGANISM SUSPENSION IS THEN ANALYZED WITH THE VITEK® OR VITEK® 2 INSTRUMENTS. THE REQUIRED MCF VALUES FOR MICROORGANISM SUSPENSIONS ARE SPECIFIED IN THE CULTURE REQUIREMENTS TABLE FOR VITEK® 2 REAGENTS. TOO LOW OR TOO HIGH MCF VALUES WHILE PREPARING ISOLATES FROM PATIENT SAMPLES CAN RESULT IN FALSE SUSCEPTIBLE OR FALSE RESISTANT RESULTS RESPECTIVELY. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503072 DENSICHEK PLUS DENSICHEK® PLUS LON BIOMÉRIEUX, INC. 21250 03573026222239

    Patients

    Seq Age Sex Outcome Treatment
    1