BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 17198948 · Received June 26, 2023

    Report

    Report Number
    9680577-2023-00030
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING MACCONKEY II AGAR, CATALOG NUMBER 254078, LOT NUMBER 3073397 WITH RESPECT TO INSUFFICIENT GROWTH. EVENT DESCRIPTION: CUSTOMER COMPLAINS THAT SOME MICROORGANISMS¿ COLONIES GROW INDISTINGUISHABLE BETWEEN SPECIES ON PRODUCT NUMBER 254078. ACCORDING TO THE CUSTOMER, SPECIES OF SERRATIA, PROVIDENCIA, S. MALTOPHILIA AND MORGANELLA ALL LOOK COLORLESS WITH THE SAME MORPHOLOGY AND SIZE AND CANNOT BE DIFFERENTIATED ON THE AGAR PLATE. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED. THERE WERE NO SIMILAR COMPLAINTS RECEIVED DURING THE PAST 12 MONTHS FOR LOT NUMBER 3073397. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES AND ALL RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: AN ANALYSIS OF GROWTH PROMOTION FOR THE MEDIA WAS PERFORMED ON RETAIN SAMPLES FOR LOT 3073397. VISUAL INSPECTION OF THE RETAIN SAMPLES WAS WITHIN SPECIFICATION WITH THE MEDIUM HAVING A LIGHT PINK, SLIGHTLY OPALESCENT APPEARANCE. THE PERFORMANCE TEST WAS CONDUCTED ACCORDING TO OUR QC RELEASE TESTING PROCEDURE USING E. COLI ATCC 25922 AND P. MIRABILIS ATCC 12453 AND ADDITIONALLY USING S. MALTOPHILIA ATCC 13637. GROWTH OF ALL STRAINS WAS SATISFACTORY WITH COLONY COLORS BEING PINK FOR E. COLI AND COLORLESS / BEIGE FOR P. MIRABILIS AND S. MALTOPHILIA. RETURN SAMPLES WERE NOT PROVIDED. HOWEVER, THE CUSTOMER SHARED PICTURES ILLUSTRATING THE ISSUE. EVALUATION RESULTS: AT THIS STAGE OF THE INVESTIGATION, ANY SYSTEMIC FAILURE IN THE MANUFACTURING PROCESSES CAN BE EXCLUDED. NO DEVIATION COULD BE FOUND DURING THE QC PERFORMANCE TEST DURING INITIAL RELEASE TESTING AND DURING THE RETAIN SAMPLE TESTING. GROWTH OF E. COLI ATCC 25922, P. MIRABILIS ATCC 12453 AND S. MALTOPHILIA ATCC 13637 WAS SATISFACTORY. WITH MACCONKEY II AGAR, DIFFERENTIATION OF ENTERIC MICROORGANISMS IS ACHIEVED BY THE COMBINATION OF LACTOSE AND THE NEUTRAL RED PH INDICATOR. COLORLESS OR PINK TO RED COLONIES ARE PRODUCED DEPENDING UPON THE ABILITY OF THE ISOLATE TO FERMENT THE CARBOHYDRATE. AS STATED IN THE IFU, E. COLI AS A LACTOSE-FERMENTER IS EXPECTED TO GROW WITH PINK COLONIES WHEREAS NON-LACTOSE-FERMENTERS LIKE P. MIRABILIS GROW WITH COLORLESS / BEIGE COLONIES. THE SAME WOULD BE EXPECTED FOR OTHER NON-LACTOSE-FERMENTERS LIKE, PROVIDENCIA SPP., MORGANELLA SPP. AND S. MALTOPHILIA. SERRATIA SPP. ARE CATEGORIZED AS LATE LACTOSE FERMENTERS. THEREFORE, DUE TO SLOW FERMENTATION, COLONIES MIGHT INITIALLY APPEAR COLORLESS, HOWEVER, MAY BECOME RED-PIGMENTED, ESPECIALLY IF THE PLATE IS LEFT AT 25°C. IN OUR RETAIN SAMPLE TESTING USING E. COLI ATCC 25922, P. MIRABILIS ATCC 12453 AND S. MALTOPHILIA ATCC 13637, COLONY MORPHOLOGY AND COLOR WERE SATISFACTORY FOR ALL TESTED STRAINS AND A PROBLEM WAS NOT DETECTED. SINCE NO TREND WAS IDENTIFIED, NO CORRECTIVE PREVENTIVE ACTION WILL BE IMPLEMENTED THIS TIME. PLEASE NOTE THAT THE MEDIUM COLOR OF CATALOG NO. 254078 IS SPECIFIED AS ¿LIGHT PINK, SLIGHTLY OPALESCENT¿ ON THE CERTIFICATE OF ANALYSIS. COLOR OF THE MEDIUM CAN BE AFFECTED BY TEMPERATURE CHANGES DURING TRANSPORT OR STORAGE AND FUNCTIONALITY OF PLATES CAN BE IMPAIRED IF MEDIUM COLOR IS NOT WITHIN SPECIFICATION. WE RECOMMEND NOT TO USE ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE SPECIFICATION AS IT IS DESCRIBED ON THE CERTIFICATE OF ANALYSIS. INVESTIGATION CONCLUSION: BASED ON THE RESULTS OF THE PERFORMED GROWTH PROMOTION TEST USING THE RETAIN SAMPLES, WE CANNOT REPRODUCE THE COMPLAINT ISSUE. BASED ON THE LAB RESULTS, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITE ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5.IT WAS REPORTED WHILE USING ONE BD BBL¿ MACCONKEY II AGAR, COLONIES WERE INDISTINGUISHABLE BETWEEN SPECIES. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH USE OF BD BBL¿ MACCONKEY II AGAR COLONIES ARE INDISTINGUISHABLE BETWEEN SPECIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPECIES OF SERRATIA, PROVIDENCIA, S. MALTOPHILIA AND MORGANELLA ALL LOOK COLORLESS, WITH THE SAME MORPHOLOGY AND SIZE AND THE CUSTOMER CANNOT BE IDENTIFIED ON THE AGAR PLATE. ADDITIONAL INFO FROM TASK: 1. WERE DIFFERENT PLATES RUN PER PATIENT? YES, CHROMAGAR ORIENTATION, TSA+5% BLOOD, CHOCOLATE AGAR. 2. WAS THE CUSTOMER STILL ABLE TO RETRIEVE THE CORRECT RESULT? YES, CORRECT RESULT WAS DUE TO CHROMAGAR ORIENTATION AND VITEK MS. 3. IF NOT, WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? N/A. 4. IF YES, WAS THERE ANY NEGATIVE IMPACT ON PATIENTS? DELAY IN RESULT BECAUSE THEY COULD NOT DIFFERENTIATE BETWEEN ISOLATES ON THE BD MACCONKEY AGAR SO THEY NEEDED TO SUBCULTURE FROM CHROMAGAR ORIENTATION AND THEN PERFORM THE ID."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH USE OF BD BBL¿ MACCONKEY II AGAR COLONIES ARE INDISTINGUISHABLE BETWEEN SPECIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPECIES OF SERRATIA, PROVIDENCIA, S. MALTOPHILIA AND MORGANELLA ALL LOOK COLORLESS, WITH THE SAME MORPHOLOGY AND SIZE AND THE CUSTOMER CANNOT BE IDENTIFIED ON THE AGAR PLATE. ADDITIONAL INFO FROM TASK: 1. WERE DIFFERENT PLATES RUN PER PATIENT? YES, CHROMAGAR ORIENTATION, TSA+5% BLOOD, CHOCOLATE AGAR 2. WAS THE CUSTOMER STILL ABLE TO RETRIEVE THE CORRECT RESULT? YES, CORRECT RESULT WAS DUE TO CHROMAGAR ORIENTATION AND VITEK MS 3. IF NOT, WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? N/A 4. IF YES, WAS THERE ANY NEGATIVE IMPACT ON PATIENTS? DELAY IN RESULT BECAUSE THEY COULD NOT DIFFERENTIATE BETWEEN ISOLATES ON THE BD MACCONKEY AGAR SO THEY NEEDED TO SUBCULTURE FROM CHROMAGAR ORIENTATION AND THEN PERFORM THE ID."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE BD BBL¿ MACCONKEY II AGAR, COLONIES WERE INDISTINGUISHABLE BETWEEN SPECIES. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478355 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 3073397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown