BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® CPS® ELITE AGAR

    MDR report key: 7071461 · Received November 30, 2017

    Report

    Report Number
    3002769706-2017-00387
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Report Date
    December 22, 2017
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JXA
    UDI-DI
    03573026443900
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: COMPLAINTS TRENDING FOR NO GROWTH/NO COLOR IN THIS MEDIA IN THE LAST THREE (3) YEARS SHOW GOOD TREND WITHOUT OUT OF CONTROL DATA AND/OR ANY WARNING RELATED WITH THIS PROBLEM. IN GENERAL THERE IS NO EVIDENCE OF ANY SYSTEMIC ISSUE RELATED WITH PRODUCT PERFORMANCE. FOR THIS PARTICULAR BATCH OF CHROMID CPSE AGAR, THERE ARE NO OTHER COMPLAINTS SINCE THE DATE OF RELEASE ON 19SEP2017 RELATED TO A PERFORMANCE ISSUE. THERE ARE NO NONCONFORMITIES ASSOCIATED WITH THE BATCH RELATED TO PRODUCT PERFORMANCE AND/OR SIMILAR IN NATURE TO THE ISSUE OBSERVED IN THE COMPLAINT REPORTED BY THE CUSTOMER. THE QUALITY CONTROL TECHNIQUE WAS REVIEWED SHOWING THAT ROUTINE POSITIVE STRAINS OF E.COLI ATCC 25922 AND E.COLI ATCC 9909604 WERE GROWING AND DEVELOPING AS SPONTANEOUS PINK TO BURGUNDY IN COLOR AS DEFINED IN THE SPECIFICATIONS. VITEK® IDENTIFICATION GAVE IN BOTH CASES E.COLI AS BIOCHEMICAL IDENTIFICATION WITH AN EXCELLENT INTERVAL OF CONFIDENCE DETECTION. BOTH CUSTOMER STRAINS EXPRESSED ONLY BETA-GAL ACTIVITY NOT BETA-GUR PATHWAY, THEREFORE, BOTH CUSTOMER STRAINS HAVE AT LEAST ONE ENZYMATIC ACTIVITY NECESSARY TO DEVELOP THE TYPICAL PINK- BURGUNDY COLOR (BETA -GAL + AND BETA-GUR - ) SO ALL COLOR DEVELOPMENT IS DUE TO BETA -GAL ACTIVITY, THEREFORE ,BOTH CLINICAL STRAINS DO NOT PRESENT AN ATYPICAL PATTERN. SAMPLES FROM THE CUSTOMER WERE INOCULATED FOR BOTH E.COLI STRAINS FOLLOWING THE QUALITY CONTROL STANDARD PROCEDURE, IN ADDITION TO THE ONES (E.COLI ATCC 25922 AND E.COLI ATCC 9909604) IN PARALLEL WITH OTHERS RETENTION SAMPLES. AFTER READING AT 33- 37 º C FOR 24 HOURS AND 48 HOURS: COMPARED E.COLI ATCC 25922 (BETA-GAL + AND BETA-GUR +) IN FRONT OF CLINICAL STRAINS WE CAN SEE HOW ENZYMATIC ACTIVITY AND THEREFORE, COLOR DEVELOPMENT IS STRONGER IN THE POSITIVE CONTROL USED IN ROUTINE QC TESTING PRIOR BATCH RELEASE. FOR QC STRAIN GROWTH AND COLOR IS MAINTAINED AND REMAINS INSIDE SPECIFICATIONS. BOTH CLINICAL STRAINS IN COMPARISON WITH E.COLI ATCC 25923 OVERALL RESULTS SHOWED LESS SPECIFICITY AND SENSITIVITY, HOWEVER, UP TO 24 HOURS THIS DIFFERENCE DISAPPEAR. REGARDING COLONY SIZE E.COLI 171030755 SHOWED BETTER RECOVERY THAN E.COLI 171020101, WHICH GAVE VARIABLE GROWTH, HOWEVER THIS ONE SHOWED A STRONGER ABILITY TO HYDROLYZE THE CHROMOGENIC SUBSTRATES WITH A RANGE OF COLOR MOVING FROM PALE PINK TO BURGUNDY THAN E.COLI 171030755 IN SPITE OF THE RATE OF GROWTH HAS BEEN WEAKER (WORSE SENSITIVITY). TO SUMMARIZE, BIOMERIEUX DID NOT CONFIRM THE SAME PROBLEM DURING A REVIEW OF THE RETENTION SAMPLES (2- 8 º C) , CONFIRMING THAT, EVEN THOUGH BOTH CUSTOMER STRAINS SHOWED LOWER INTENSITY OF COLORATION AND RECOVERY RATE THAN OUR QC STRAINS ,BOTH HAVE AT LEAST ONE ENZYMATIC ACTIVITY NECESSARY TO DEVELOP THE TYPICAL PINK-BURGUNDY COLOR (BETA-GAL + AND BETA-GUR - ). THE MEDIUM THE CUSTOMER COMPLAINED ABOUT IS WORKING WELL DURING INTERNAL TESTING; BOTH CLINICAL STRAINS FROM THE CUSTOMER WERE RECOVERED AS PINK IN EITHER 24 OR 48 HOURS, NOT PRODUCING FALSE-NEGATIVE REACTIONS. IN ORDER TO CHECK THE IMPACT OF THE LIGHT AS A POSSIBLE ROOT CAUSE TO EXPLAIN THE CUSTOMER PROBLEM, SOME PLATES FROM THE RETENTION SAMPLE WERE PLACED IN THE QC LAB AND EXPOSED TO AMBIENT LIGHT FOR 8 HOURS BEFORE THEIR INOCULATION. FOLLOWING INCUBATION, THE PERFORMANCE OF THE MEDIA CHANGED IN REGARDS TO THE FINDINGS OBSERVED WITH STANDARD CONDITIONS (2-8 º C), WORSE PERFORMANCE, GETTING COLORLESS COLONIES FOR E.COLI 171030755. THEREFORE, IT WAS AFFECTED BY THE LIGHT EXPOSURE WHEREAS E.COLI 171020101 WAS NOT IMPACTED, OBTAINING THE SAME RESULTS THAN THE ONES ON STANDARD PLATES (2-8 º C), NEVERTHELESS, UP TO 24 HOURS: E.COLI 171030755 DEVELOP AS VERY PALE PINK COLONIES. E.COLI 171020101 DEVELOP AS BURGUNDY COLONIES. ACCORDING TO THESE RESULTS WE CAN CONCLUDE THAT: THE MOST LIKELY ROOT CAUSE OF THE CUSTOMER COMPLAINT WAS DUE TO LIGHT EXPOSURE, FOR WHICH REASON IT IS IMPORTANT TO STRICTLY FOLLOW THE INSTRUCTIONS FOR USE (IFU); CHROMOGENIC MEDIA SHOULD REMAIN PROTECTED FROM LIGHT EXCEPT FOR THE STREAKING AND THE READING. ALTHOUGH THE SENSITIVITY AND SPECIFICITY ARE LOWER THAN WHAT WAS OBSERVED WITH THE QC INTERNAL STRAINS, BOTH WERE RECOVERED AS PINK EITHER IN 24 OR 48 HOURS , NOT PRODUCING FALSE-NEGATIVE REACTIONS, TAKING INTO CONSIDERATION THAT: E.COLI 171030755 HAS A REDUCED SPECIFICITY IN REGARDS TO THE INTENSITY OF COLOR; BETA-GAL ACTIVITY IS SLIGHTLY EXPRESSED E.COLI 171020101 HAS A REDUCED SENSITIVITY IN REGARDS TO THE COLONY SIZE AND THE GROWTH RATE, GIVING A VARIABLE GROWTH AND COLONIES COLOR, SUGGEST US THAT THIS VARIABILITY IS NOT LINKED WITH THE COMPLAINED BATCH, COULD BE RELATED STRAIN ITSELF. BOTH STRAINS EXPRESSED ONLY BETA-GAL ACTIVITY NOT BETA-GUR PATHWAY, THIS EXPLAINS THE LESS SENSITIVITY OBSERVED IN COMPARISON WITH OUR ATCC STRAIN; THEREFORE, THE MEDIUM IS WORKING ACCORDING ITS SPECIFICATIONS AND BOTH CLINICAL STRAINS DO NOT PRESENT AN ATYPICAL PATTERN. AS DEFINED IN THE PACKET INSERT, WE DO NOT DESCRIBE 100% SENSITIVITY. IN ANY CASE, EVEN UNDER LIGHT EXPOSURE, WE DID NOT REPRODUCE CUSTOMER ISSUE; WE THINK THAT MAIN ROOT CAUSE COULD BE: WE DID NOT RECEIVE THE SAME STRAINS THAT THE CUSTOMER COMPLAINED ABOUT. PLATES FROM THE CUSTOMER WERE SUBJECT TO MORE AGGRESSIVE CONDITIONS THAN THE ONES WE TRIED TO SIMULATE IN OUR LAB (EIGHT (8) HOURS OF LIGHT EXPOSURE).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR TWO ESCHERICHIA COLI STRAINS. THE TWO STRAINS WERE GROWING IN WHITE COLONIES, RATHER THAN THE CHARACTERISTICALLY PINK COLONIES, ON CHROMID® CPS® ELITE MEDIA PLATE, LOT 1005953180. THE IDENTIFICATION OF THE STRAINS WERE CONFIRMED AS ESCHERICHIA COLI BY MALDI-TOF. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849219 CHROMID® CPS® ELITE AGAR CHROMID® CPS® ELITE AGAR JXA BIOMÉRIEUX SA 1005953180 03573026443900

    Patients

    Seq Age Sex Outcome Treatment
    1