API LISTERIA 10STRIPS+10MEDIA
Report
- Report Number
- 9615754-2023-00042
- Event Type
- Malfunction
- Date Received
- October 10, 2023
- Report Date
- February 29, 2024
- 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
THE MDR GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016", SECTION 2.15, ESTABLISHES THAT ONCE A MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, A PRESUMPTION THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY HAS BEEN ESTABLISHED. BIOMÉRIEUX HAS PERFORMED A REVIEW AND ANALYSIS OF THE MDR SUBMISSIONS, SPECIFIC TO THE BIOMÉRIEUX API REAGENTS. THE REVIEW INCLUDED MDRS SUBMITTED TO THE FDA FROM 01-JAN-2022 TO 22-FEB-2024. BASED UPON OUR REVIEW AND ANALYSIS OF BIOMÉRIEUX API REAGENT MDR SUBMISSIONS, THERE HAVE BEEN NO CUSTOMER CLAIMS OF DEATH OR SERIOUS INJURY WITHIN THE PAST TWO (2) YEARS. EACH HAS BEEN INVESTIGATED OR IS CURRENTLY UNDERGOING INVESTIGATION, AND ANY ISSUES HAVE BEEN ADDRESSED BY THE MANUFACTURING SITE. WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR API REAGENTS. MALFUNCTION EVENTS FOR MEDICAL DEVICE PROBLEM CODE: A090811 - UNABLE TO OBTAIN READINGS WILL NO LONGER BE REPORTED FOR ALL API REAGENTS (PRODUCT CODES: JSC, JSH, JSP, JSS, JSW, JTO, JWX, JXB, PTJ) AS THESE EVENTS ARE NOT "LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY" IF THEY WERE TO RECUR. MOVING FORWARD, IF WE BECOME AWARE OF A DEATH OR SERIOUS INJURY EVENT RELATED TO UNABLE TO OBTAIN READINGS OBTAINED WITH AN API REAGENT, WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE AND UPDATE OUR MDR CRITERIA TO INCLUDE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THE MDR GUIDANCE.
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.1010042770, EXP DATE: 3/21/2024). A RELATED COMPLAINT (B)(4) WAS CREATED TO DOCUMENT THE SAME ISSUE OBTAINED BY THE SAME CUSTOMER, SAME PRODUCT BUT DIFFERENT LOT NUMBER. 009868240) 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. 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).
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 10 STRIPS+10MEDIA - 10300, LOT# 1010042770, EXP DATE: 3/21/2024. 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) : 2 LOTS : 009868240 AND 1010042770. MATRIX: CUSTOMER 1: BUTTER AND RAW FRESH TOMME CHEESE MATRIX CUSTOMER 2 EIL REYMA: MILK POWDER: SAMPLES 852352, 674064 AND 888865 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 |
|---|---|---|---|---|---|---|---|
| 346886 | API LISTERIA 10STRIPS+10MEDIA | API LISTERIA 10STRIPS+10MEDIA | JTO | BIOMERIEUX, SA | 1010042770 | 03573026035587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |