BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID CPS ELITE

    MDR report key: 10820964 · Received November 11, 2020

    Report

    Report Number
    9615755-2020-00030
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JXA
    UDI-DI
    03573026468828
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2020 A CUSTOMER FROM HONG KONG NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED LOW/NO GROWTH WHEN GROWING TWO STAPHYLOCOCCUS SAPROPHYTICUS ISOLATES ON CHROMID CPS ELITE (CPSE) 20 PLT TRANS (REF. 418284; LOT 1008224360). BIOMÉRIEUX PERFORMED AN INTERNAL INVESTIGATION. THE COMPLAINT LABORATORY TESTED THE CUSTOMER¿S IMPACTED LOT AS WELL AS RETAINED SAMPLES FROM THREE OTHER LOTS. A FRESH LOT (NUMBER 1008400050) OF CHROMID CPSE, EXPIRY DATE 10- MARCH-2021 WAS TESTED IN ORDER TO DEMONSTRATE IF THE PRODUCT SENSITIVITY COULD CHANGE ALONG THE SHELF LIFE OF THE PRODUCT. TWO OTHER CHROMID CPSE LOTS WITH THE SIMILAR EXPIRED DATE OF THE CUSTOMER¿S LOT WERE ALSO TESTED (LOT 1008225240, EXPIRY DATE 01-DECEMBER-2020 AND LOT 1008214940, EXPIRY DATE 25-NOVEMBER-2020). SEVERAL QUALITY CONTROL STRAINS WERE USED: ESCHERICHIA COLI ATCC® 25922¿ AND E.COLI 9909604; KESC STRAIN: KLEBSIELLA PNEUMONIAE ATCC® 13883¿; PROTEEAE STRAIN: PROTEUS MIRABILIS ATCC® 12453¿; ENTEROCOCCUS FAECALIS ATCC® 29212¿; STREPTOCOCCUS AGALACTIAE ATCC® 12386¿; STAPHYLOCOCCUS AUREUS ATCC® 25923¿. ADDITIONALLY, THEY TESTED STAPHYLOCOCCUS SAPROPHYTICUS ATCC® 15305¿ FROM THE BIOMÉRIEUX INTERNAL COLLECTION. THIS STRAIN WAS CHOSEN TO SPECIFICALLY TEST THE REPORTED ISSUE REGARDING LACK OF GROWTH FOR S. SAPROPHYTICUS (THE PATIENT STRAIN). THE RESULTS OBTAINED WERE AS EXPECTED AND MET THE SPECIFICATIONS FOR ALL OF THE ATCC® ¿ STRAINS. GOOD GROWTH OF S. SAPROPHYTICUS ATCC 15305, WAS ALSO OBSERVED. PATIENT STRAIN TESTING: THE CUSTOMER SUBMITTED TWO TUBES OF THE PATIENT¿S STRAIN (COMING FROM ONE PATIENT URINE SAMPLE) FOR INVESTIGATIONAL TESTING. RETAINED SAMPLES OF THE CUSTOMER LOT WERE USED TO TEST THE STRAIN (FROM TUBE 1 AND 2) IN PARALLEL WITH RETAINED SAMPLES FROM THREE OTHER LOTS. THE LOTS TESTED WERE A FRESH LOT OF CPSE (LOT 1008430480, EXPIRY DATE 28- MARCH-2021) AS WELL AS TWO OTHERS WITH SIMILAR EXPIRY DATES TO THE CUSTOMER LOT (LOT 1008225240, EXPIRY DATE 01-DECEMBER-2020, LOT 1008214940, EXPIRY DATE 25-NOVEMBER-2020). USING A VITEK® 2 SYSTEM, THE COMPLAINT LABORATORY CONFIRMED THE IDENTIFICATION OF THE PATIENT STRAIN AS S. SAPROPHYTICUS. RESULTS ON THE CHROMID PLATES SHOWED TOTAL INHIBITION OR A SINGLE CFU (COLONY FORMING UNIT) ON ALL PLATES TESTED; CONFIRMING THE CUSTOMER¿S COMPLAINT. IT WAS CONCLUDED THAT LACK OF GROWTH WAS NOT LOT DEPENDENT. THE LACK OF GROWTH OF THE PATIENT STRAIN STAPHYLOCOCCUS SAPROPHYTICUS WAS REPRODUCED, BUT THE QUALITY CONTROL TESTS PERFORMED DURING THE INVESTIGATION DID NOT HIGHLIGHT A DEVIATION IN THE QUALITY OF THE PRODUCT. THE LOT NUMBERS RECORD ANALYSIS INDICATED THAT THE IMPACTED LOT COMPLIES WITH OUR SPECIFICATIONS. IN ADDITION, THE STRAIN STAPHYLOCOCCUS SAPROPHYTICUS ATCC 15305 WERE ALSO TESTED WITH THE IMPACTED LOT, AND THE RESULT WAS GOOD GROWTH. THE INVESTIGATION CONCLUDED THAT THE LACK OF GROWTH OBSERVED IS LINKED TO THE SPECIFIC PATIENT STRAIN REQUIREMENTS. THIS SITUATION IS DESCRIBED IN THE PACKAGE INSERT OF CPSE PRODUCT WITH THE FOLLOWING SENTENCE: ¿ GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICROORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS WHICH HAVE SPECIFIC REQUIREMENTS (SUBSTRATE, TEMPERATURE, INCUBATION CONDITIONS, ETC.) MAY NOT DEVELOP ON THE MEDIUM.¿ BIOMÉRIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE AND DETERMINED THAT THE OVERALL RISK IS MINOR. FURTHERMORE, NO OTHER COMPLAINTS WERE REGISTERED ON THE IMPACTED LOT AND SINCE NOVEMBER 2019 NO OTHER COMPLAINT FOR THIS KIND OF ISSUE HAS BEEN REGISTERED FOR CPSE PRODUCT. THIS CHARACTERISTIC OF CPS ELITE HAS ALREADY BEEN TAKEN INTO ACCOUNT BY R&D FOR ONGOING IMPROVEMENT OF THE SENSITIVITY OF THE MEDIUM FOR STAPHYLOCOCCUS SAPROPHYTICUS STRAINS.

    Description of Event or Problem · 1

    CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ON (B)(6) 2020 A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED LOW/NO GROWTH WHEN GROWING (B)(6) SAPROPHYTICUS ON CHROMID® CPS ELITE (CPSE) AGAR (REF. 418284; LOT 1008224360). THE CUSTOMER STATED HE INOCULATED A URINE SPECIMEN ON BOTH CPSE AGAR AND COLUMBIA AGAR + 5% SHEEP BLOOD (COS). GOOD GROWTH WAS OBSERVED ON THE COS AGAR. S. SAPROPHYTICUS WAS FURTHER CONFIRMED BY VITEK® MS WITH 99.9%. ON CPSE AGAR, NO S. SAPROPHYTICUS GROWTH WAS OBSERVED. THE CUSTOMER SUB-CULTURED THE SPECIMEN FROM THE COS PLATE TO CPSE AGAR AND COS AGAR, AND THE NEXT DAY OBSERVED GOOD GROWTH OF S. SAPROPHYTICUS (IDENTIFIED BY VITEK® MS WITH 99.9%) ON COS AGAR AND VERY LOW GROWTH ON THE CPSE AGAR. THE CUSTOMER STATED THAT ATCC® 15305¿ (S. SAPROPHYTICUS) AND OTHER SUGGESTED ATCC STRAINS WERE VERIFIED ON THIS BATCH OF AGAR. ALL ATCC PERFORMED WELL AND ATCC 15305 HAD GOOD GROWTH ON THIS CPSE AGAR. AS INDICATED IN THE INSTRUCTION FOR USE, SECTION LIMITATIONS OF THE METHOD: ¿GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICROORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS WHICH HAVE SPECIFIC REQUIREMENTS (SUBSTRATE, TEMPERATURE, INCUBATION CONDITIONS, ETC.) MAY NOT DEVELOP ON THE MEDIUM.¿ THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289971 CHROMID CPS ELITE CHROMID® CPS ELITE JXA BIOMÉRIEUX SA 1008224360 03573026468828

    Patients

    Seq Age Sex Outcome Treatment
    1