BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API LISTERIA 10STRIPS+10MEDIA

    MDR report key: 17903255 · Received October 10, 2023

    Report

    Report Number
    9615754-2023-00041
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Report Date
    December 28, 2023
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JTO
    UDI-DI
    03573026035587
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: AN INDUSTRY CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF UNACCEPTABLE PROFILE RESULT OBTAINED WITH LISTERIA MONOCYTOGENES IN ASSOCIATION WITH API LISTERIA 10STRIPS+10MEDIA - 10300, LOT.1009868240, EXP DATE: 11/24/2023). A RELATED COMPLAINT (B)(4) WAS CREATED TO DOCUMENT THE SAME ISSUE OBTAINED BY THE SAME CUSTOMER, SAME PRODUCT BUT DIFFERENT LOT NUMBER: 1010042770. RESULTS ARE SUMMARIZED BELOW: API LISTERIA -REF:(B)(4)LOTS : 009868240 AND 1010042770). MATRIX: CUSTOMER 1: BUTTER AND RAW FRESH TOMME CHEESE MATRIX CUSTOMER 2 EIL REYMA: MILK POWDER: SAMPLES (B)(6). MALDI-TOF VERIFICATION: PROFILE MATCHES LISTERIA MONOCYTOGENES FOR ALL 6 STRAINS. INVESTIGATION: BATCH HISTORY RECORD AND COMPLAINT TREND ANALYSIS. THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE CONCLUDED WITH NO IMPLICATION OF A TREND. THIS COMPLAINT HAS NOT BEEN IDENTIFIED AS A SYSTEMIC QUALITY ISSUE. INVESTIGATION RESULTS A REVIEW OF THE PRODUCTION AND QUALITY CONTROL DATA FOR THE TWO BATCHES DID NOT REVEAL ANY DEFECTS OR ANOMALIES THAT MIGHT EXPLAIN THE PROBLEM ENCOUNTERED. TESTS CARRIED OUT ACCORDING TO QUALITY CONTROL PROTOCOL ON SAMPLES OF BOTH BATCHES COMPLY WITH BIOMÉRIEUX SPECIFICATIONS. THE PERFORMANCE OF THESE BATCHES IS THEREFORE NOT CALLED INTO QUESTION. SUMMARY OF INVESTIGATION RESULTS: - THE IDENTIFICATION OF 2 STRAINS RETURNED BY THE CUSTOMER WERE CONFIRMED AS LISTERIA MONOCYTOGENES BY VITEK MS. - THE 2 STRAINS RETURNED BY THE CUSTOMER WERE TESTED ON API LISTERIA STRIPS : LOT 1010042770 RELATED TO THE COMPLAINT AND LOT BLISTER 1010160290 (FINISH PRODUCT 1010160300) USED AS REFERENCE LOT. THE LOT NUMBER 1009868240 ALSO RELATED TO COMPLAINT CAN NOT BE TESTED BECAUSE THIS LOT WAS EXPIRED. THE 2 STRAINS TESTED GAVE A GOOD IDENTIFICATION TO LISTERIA MONOCYTOGENES ON THE 2 API LISTERIA LOTS TESTED (PROFIL 6510). THE DIFFERENCE BETWEEN THE CUSTOMER RESULTS AND THE INVESTIGATION RESULTS CONCERNED THE RIB AND TAG TESTS WHICH WERE OBTAINED POSITIVE BY THE CUSTOMER WHILE THEY ARE EXPECTED NEGATIVE FOR A LISTERIA MONOCYTOGENES STRAIN. CONCLUSION: - NO NON CONFORMITIES REGISTERED DURING MANUFACTURING AND QUALITY CONTROL PROCESSES FOR THE 2 LOT NUMBERS RELATED TO THE COMPLAINTS (LOTS 1009868240 AND 1010042770). - NO PRODUCT PERFORMANCE ISSUE DETECTED DURING QC INVESTIGATION ON THE 2 LOTS RELATED TO THE COMPLAINTS (LOTS 1009868240 AND 1010042770) BY USING THE 3 QC STRAINS INCLUDED IN THE PACKAGE INSERT. - CUSTOMER ISSUE NOT REPRODUCED DURING INVESTIGATION TESTS BY USING THE 2 STRAINS RETURNED BY THE CUSTOMER ON THE LOT NUMBER 1010042770 RELATED TO THE COMPLAINT (LOT NUMBER 1009868240 NOT TESTED BECAUSE EXPIRED WHEN INVESTIGATION TESTS WERE PERFORMED).

    Description of Event or Problem · 0

    INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. THE COMPLETE LIST OF THOSE ORGANISMS THAT IT IS POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE TECHNICAL BROCHURE - INFORMATION FOR IDENTIFICATION SOFTWARE. ISSUE DESCRIPTION: AN INDUSTRY CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF UNACCEPTABLE PROFILE RESULT OBTAINED WITH LISTERIA MONOCYTOGENES IN ASSOCIATION WITH API LISTERIA 10STRIPS+10MEDIA - 10300, LOT. 1009868240, EXP DATE: 11/24/2023). A RELATED COMPLAINT (B)(4) WAS CREATED TO DOCUMENT THE SAME ISSUE OBTAINED BY THE SAME CUSTOMER, SAME PRODUCT BUT DIFFERENT LOT NUMBER. RESULTS ARE SUMMARIZED BELOW: API LISTERIA -REF:10300-(LOTS : 009868240 AND 1010042770) MATRIX: CUSTOMER 1: BUTTER AND RAW FRESH TOMME CHEESE MATRIX CUSTOMER 2 EIL REYMA: MILK POWDER: SAMPLES (B)(6). MALDI-TOF VERIFICATION: PROFILE MATCHES LISTERIA MONOCYTOGENES FOR ALL 6 STRAINS. CUSTOMER REPORTED THAT ON SEVERAL GALLERIES OF THE ABOVE-MENTIONED BATCHES, THEY OBTAINED PROFILE 6531 WHICH GIVES AN "UNACCEPTABLE PROFILE" RESULT. IDENTIFICATION WERE DONE WITH 2 DIFFERENT TECHNICIANS ON 2 DIFFERENT BATCHES. AFTER SEVERAL TESTS, THEY OBTAINED LISTERIA MONOCYTOGENES PROFILES, BUT THIS WAS RANDOM. DOUBTING THE RESULTS, CUSTOMER PRODUCED SEVERAL GALLERIES (DIFFERENT BATCHES) FOR THE SAME STRAIN WHICH CAUSED DELAYED RESULTS. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY CUSTOMER'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346884 API LISTERIA 10STRIPS+10MEDIA API LISTERIA 10STRIPS+10MEDIA JTO BIOMERIEUX, SA 1009868240 03573026035587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown