BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELOSE CHROMID CPS ELITE AGAR

    MDR report key: 10997869 · Received December 13, 2020

    Report

    Report Number
    9615755-2020-00033
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Report Date
    March 30, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JXA
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN BRAZIL REGARDING INCORRECT COLOR DIFFERENTIATION WHEN TESTING A CITROBACTER FREUNDII ISOLATE AND GROWTH INHIBITION OF A STAPHYLOCOCCUS SAPROPHYTICUS ISOLATE IN ASSOCIATION WITH THE GELOSE CHROMID® CPS ELITE AGAR (REF. (B)(4), LOT 1008340740). THE CUSTOMER STATED THE CITROBACTER FREUNDII WERE BURGUNDY IN COLOR, INDICATIVE OF ESCHERICHIA COLI. THE EXPECTED COLONY COLOR FOR CITROBACTER FREUNDII WAS TURQUOISE. THE ENVIRONMENTAL CONTROLS PERFORMED DURING THE MANUFACTURING OF LOT 1008340740 WAS IN ACCORDANCE WITH THE SPECIFICATIONS. THE EQUIPMENT AND INSTRUMENTS USED WERE QUALIFIED AND CALIBRATED. THE QUALITY CONTROL (QC) TESTS PERFORMED BEFORE THE LOT WAS RELEASED WERE ALSO WITHIN PRODUCT SPECIFICATIONS. THE STRAINS IN QUESTION AND IMPACTED PLATES WERE NOT AVAILABLE FOR INVESTIGATION. TESTING WAS PERFORMED ON THE RETAIN SAMPLES OF LOT 1008340740 IN ORDER TO VERIFY IF THE MICROBIOLOGICAL PERFORMANCE WAS IN ACCORDANCE WITH QC. THE IMPACTED LOT WAS TESTED IN PARALLEL WITH A REFERENCE LOT NUMBER: 1008441830 EXPIRY DATE: 08-APRIL-2021 TO COMPARE THE PERFORMANCE BETWEEN LOTS. A TOTAL OF ELEVEN (11) ATCC® AND INTERNAL QC STRAINS WERE TESTED AS PART OF THIS INVESTIGATION. ALL THE RESULTS OBTAINED FOR GROWTH, STRAIN IDENTIFICATION AND STRAIN COLOR AFTER INCUBATION WERE IN ACCORDANCE WITH THE SPECIFICATIONS, INCLUDING THE CITROBACTER STRAINS AND STAPHYLOCOCCUS SAPROPHYTICUS STRAINS THAT WERE THE OBJECTIVE OF OUR INVESTIGATION. BIOMERIEUX DID NOT OBSERVE ANY DIFFERENCES IN RESULTS BETWEEN THE IMPACTED LOTS AND THE REFERENCE LOT. AS THE PERFORMANCE OF GELOSE CHROMID® CPS ELITE AGAR LOT 1008340740 IS WITHIN SPECIFICATIONS AND THE INVESTIGATION DID NOT REPRODUCE THE PROBLEM OBSERVED BY THE CUSTOMER, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED. THE PACKAGE INSERT OF GELOSE CHROMID® CPS ELITE AGAR ON METHODOLOGY LIMITS DESCRIBES THAT CERTAIN TYPES OF CITROBACTER CAN DEVELOP THE SAME STRAIN COLOR OF ESCHERICHIA COLI STRAIN.

    Description of Event or Problem · 1

    NOTE: THE PRODUCT, GELOSE CHROMID CPS ELITE (REFERENCE 421151), IS NOT APPROVED, SOLD MARKETED, OR DISTRIBUTED IN THE UNITED STATE. HOWEVER, A SIMILAR PRODUCT, CHROMID CPS ELITE (REFERENCE 418284) IS APPROVED. A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF INCORRECT COLOR DIFFERENTIATION WHEN TESTING A CITROBACTER FREUNDII ISOLATE AND GROWTH INHIBITION OF A STAPHYLOCOCCUS SAPROPHYTICUS ISOLATE IN ASSOCIATION WITH THE GELOSE CHROMID® CPS ELITE AGAR (REF. 42115, LOT 1008340740). THE CUSTOMER STATED THE CITROBACTER FREUNDII WERE BURGUNDY IN COLOR, INDICATIVE OF ESCHERICHIA COLI. THE EXPECTED COLONY COLOR FOR CITROBACTER FREUNDII WAS TURQUOISE. THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE IMPACTED CITROBACTER FREUNDII AND STAPHYLOCOCCUS SAPROPHYTICUS AGAR PLATES.. BIOMERIEUX CUSTOMER SERVICE REVIEWED THE PROVIDED PHOTOGRAPHS AND FOUND THE STAPHYLOCOCCUS SAPROPHYTICUS PLATE HAD A MIXED CULTURE. GREEN, WHITE, AND PINK COLONY TYPES WERE PRESENT, PINK BEING INDICATIVE OF STAPHYLOCOCCUS SAPROPHYTICUS. CUSTOMER SERVICE REQUESTED THE CUSTOMER REPEAT TESTING WITH PURE CULTURE, RESULTS HAVE NOT YET BEEN PROVIDED BIOMERIEUX CUSTOMER SERVICE ALSO CONFIRMED THAT THE GELOSE CHROMID® CPS ELITE AGAR INSTRUCTIONS FOR USE STATE CERTAIN SPECIES MAY PRODUCE COLONIES OF THE SAME CHARACTERISTIC COLOR AS E. COLI AND PROVIDES CITROBACTER AS AN EXAMPLE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464225 GELOSE CHROMID CPS ELITE AGAR GELOSE CHROMID CPS ELITE AGAR JXA BIOMÉRIEUX SA 1008340740

    Patients

    Seq Age Sex Outcome Treatment
    1