API 20 NE 25STRIPS+25MEDIA

Additional Manufacturer Narrative

FOLLOWING THE REVIEW OF A SCIENTIFIC PUBLICATION (PUBLICATION 293705000 BA 20050 ASSOCIATED WITH MISIDENTIFICATION OF TWO PASTEURELLA MULTOCIDA STRAINS BY USING API 20 NE PRODUCT REFERENCE 20050 AN INVESTIGATION HAS BEEN CARRIED OUT AT BIOMÉRIEUX MANUFACTURING SITE. A COMPLAINT TREND ANALYSIS WAS PERFORMED ON API 20 NE PRODUCT REFERENCE 20050 SINCE 2021. NO TREND RELATED TO PERFORMANCE ISSUE AND PARTICULARLY RELATED TO THE ISSUE DESCRIBED IN THE ARTICLE WAS OBSERVED. THE BIOCHEMICAL PROFILES OBTAINED ON THOSE TWO MIS-IDENTIFIED STRAINS WERE ANALYZED BY BIOMÉRIEUX GLOBAL INVESTIGATORS THAT CONFIRMED THAT THE PROFILES OBTAINED ON THOSE TWO STRAINS WERE UNUSUAL FOR P. MULTOCIDA. IN ADDITION, THOSE 2 STRAINS DID GROW ON MAC CONKEY PRODUCT WHILE THE EIGHT OTHER STRAINS IDENTIFIED AS P. MULTOCIDA DID NOT GROW ON MAC CONKEY PRODUCT. THIS INFORMATION CONFIRMS THAT THOSE TWO STRAINS ARE UNUSUAL ORGANISMS (THEY DO NOT PRESENT THE TYPICAL CHARACTERISTICS OF P. MULTOCIDA). THE ROOT CAUSE OF THE TWO MIS IDENTIFICATIONS REPORTED IN THE ARTICLE IS MOST PROBABLY SAMPLES RELATED (THE TWO STRAIN HAVING AN ATYPICAL BIOCHEMICAL PROFILE) OR ASSOCIATED WITH A CONTAMINATION THAT MAY HAVE INTERFERED WITH THE EXPECTED RESULT. IN ANY CASE THERE IS NO EVIDENCE OF ANY REGRESSION WITHIN THE PRODUCT PERFORMANCE OF API 20 NE REFERENCE 20050.

Description of Event or Problem

PRODUCT DESCRIPTION API® 20 NE IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS (FOR EXAMPLE, PSEUDOMONAS, ACINETOBACTER, MORAXELLA, VIBRIO, AEROMONAS). 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. COMPLAINT DESCRIPTION AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION (PUBLICATION 293705000 BA 20050) ENTITLED: "MORPHOLOGY, BIOCHEMICAL, AND MOLECULAR CHARACTERIZATION OF PASTEURELLA MULTOCIDA CAUSING HEMORRHAGIC SEPTICEMIA IN INDONESIA". BIOMÉRIEUX R&D AND MEDICAL AFFAIRS HAVE REVIEWED THE PUBLICATION. THIS STUDY DESCRIBES THE IDENTIFICATION OF TEN (10) ISOLATES OF PASTEURELLA MULTOCIDA CAUSING SEVERE ILLNESS IN INDONESIAN LIVESTOCK. API 20NE WAS COMPARED TO TRADITIONAL BIOCHEMICAL TECHNIQUES AND MOLECULAR TECHNIQUES. EIGHT OUT OF TEN ISOLATES WERE CORRECTLY IDENTIFIED AS P. MULTOCIDA BY API; HOWEVER, TWO (2) WERE INCORRECTLY IDENTIFIED AS AEROMONAS HYDROPHILA AND VIBRIO PARAHAEMOLYTICUS. BOTH ISOLATES WERE CONFIRMED AS P. MULTOCIDA BY MOLECULAR METHODS, AND SHOWED PINK COLONIES ON MACCONKEY AGAR, AN UNUSUAL PHENOTYPE FOR THIS ORGANISM. THE PROFILES OBTAINED ON THOSE TWO STRAINS ARE NOT COMPATIBLE WITH THE P. MULTOCIDA BIOCHEMICAL PROFIL (TOO MANY DIFFERENCES, LARGE NUMBER OF POSITIVE TESTS EXPECTED COMPARED TO VERY FEW ONES FOR P. MULTOCIDA). THESE OBSERVATIONS MEAN THAT THE TWO STRAINS PRESENT BIOCHEMICAL REACTION THAT ARE NOT USUAL FOR P. MULTOCIDA. THE AUTHORS USED THE API 20NE KIT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DESCRIBED METHODOLOGIES USED IN THIS STUDY ARE CONSISTENT WITH STANDARD PRACTICE. PASTEURELLA MULTOCIDA IS AN IMPORTANT PATHOGEN, AND ACCURATE IDENTIFICATION CAN ENABLE CORRECT ANTIMICROBIAL THERAPY. THIS ORGANISM IS A CLAIMED SPECIES FOR API 20NE, AND WOULD BE EXPECTED TO BE IDENTIFIED WITH ROUTINE TESTING. THERE IS NO INDICATION OR REPORT THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

Additional Manufacturer Narrative

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: A090805 - INCORRECT MEASUREMENT 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 FALSE SUSCEPTIBLE RESULTS 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.