API 20 E 25STRIPS

Description of Event or Problem

INTENDED USE: API® 20 E IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF ENTEROBACTERIACEAE AND OTHER NON-FASTIDIOUS GRAM-NEGATIVE RODS. 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. A CUSTOMER IN ITALY REPORTED TO BIOMÉRIEUX AN ISSUE OF NO RESULT IN ASSOCIATION WITH THE PRODUCT API 20 E 25 STRIPS (REF: 20100, BATCH NUMBER: 1009005850, EXPIRY DATE: 22-FEB-2023). CUSTOMER STATED THAT WHEN INOCULATING SOME BACTERIAL STRAINS TO CONFIRM AN IDENTIFICATION CARRIED OUT ON ANOTHER INSTRUMENT (WALK AWAY), THEY NOTICED THAT ON THE API 20 E STRIPS WITH LOT 1009005850 THERE WAS NO COLOR CHANGE ON THE FIRST PART WHERE THE AUXILIARY REAGENTS ARE PLACED AND ON THE SECOND PART WHERE THE SECOND PART OF THE SUGARS REMAINED BLUE WITHOUT ANY COLOR CHANGE TO YELLOW. THE CLIENT HAD A SUSPICION OF SALMONELLA AND AS THEY HAD 4 OTHER PACKAGES OF A NEW BATCH OF API 20 E STRIPS (LOT#: 1009469700) IN THE LABORATORY THEY INOCULATED THE SAME STRAIN ON BOTH TUNNELS OF 2 DIFFERENT BATCHES. THE CLIENT OBTAINED THE FOLLOWING RESULTS: NO REACTION (COLOR CHANGE ON LOT NUMBER 1009005850) WHILE ON LOT NUMBER 1009469700 THE RESULTS WERE COMPLIANT WITH THE EXPECTATION. 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 THE PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

CONTEXT: A CUSTOMER IN ITALY REPORTED TO BIOMÉRIEUX AN ISSUE OF NO RESULT IN ASSOCIATION WITH THE PRODUCT API 20 E 25STRIPS (REF 20100, BATCH NUMBER 1009005850, EXPIRY DATE 22-FEB-2023), NO REACTION WERE OBSERVED ON THE STRIP. IT WAS REPORTED THAT THE SAME STRAIN WAS TESTED ON ANOTHER API 20 E LOT NUMBER (LOT 1009469700, EXPIRY DATE 05 DEC 2023) AND THE IDENTIFICATION RESULT WAS SALMONELLA. INVESTIGATION: BATCH HISTORY RECORD AND TREND ANALYSIS THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE WITH NO IMPLICATION OF A TREND. INVESTIGATION RESULTS THE RETAINED SAMPLES FOR THE IMPACTED LOT NUMBER 1009005850 WAS TESTED IN PARALLEL WITH AN INTERNAL LOT NUMBER USED AS A REFERENCE LOT (REFERENCE (B)(4), LOT 1009469700). THE INVESTIGATION WAS PERFORMED BY USING THE ATCC QUALITY CONTROL (QC) STRAINS MENTIONED IN THE API 20 E PACKAGE INSERT (PROTEUS MIRABILIS ATCC 35659, STENOTROPHOMONAS MALTOPHILIA ATCC 51331, ENTEROBACTER CLOACAE SSP CLOACAE ATCC 13047, ESCHERICHIA COLI ATCC 25922 AND KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE ATCC 35657). FURTHERMORE, TWO INTERNAL STRAINS OF SALMONELLA SPP INCLUDED IN THE QUALITY CONTROL PROCEDURE WERE TESTED. THESE SEVEN STRAINS WERE TESTED ACCORDING TO THE PROTOCOL USED TO RELEASE EACH LOT NUMBER. THE QC RESULTS OBTAINED FOR THE SEVEN STRAINS TESTED ARE IN ACCORDANCE WITH THE EXPECTED SPECIFICATIONS FOR THE IMPACTED LOT AND THE REFERENCE LOT TESTED. NO ISSUE RELATED TO NO REACTION IN THE STRIPS WERE OBSERVED DURING THE INVESTIGATION FOR BOTH LOTS TESTED. IN ADDITION, THE RESULTS OBTAINED WERE EQUIVALENT ON BOTH LOTS TESTED. CONCLUSION: THE ISSUE HAS NOT BEEN REPRODUCED INTERNALLY. THE SEVEN STRAINS TESTED ON THE RETAINED SAMPLES COMPLIED WITH SPECIFICATIONS FOR THE IMPACTED LOT NUMBER 1009005850. THESE STRAINS TESTED INCLUDED TWO INTERNAL SALMONELLA STRAINS. NO ISSUE RELATED TO NO REACTION IN THE STRIPS WERE OBSERVED DURING THE INVESTIGATION FOR BOTH LOTS TESTED. IN ADDITION, EQUIVALENT RESULTS WERE OBTAINED ON THE IMPACTED LOT NUMBER 1009005850 AND ON THE LOT NUMBER USED AS A REFERENCE LOT FOR THE SEVEN STRAINS TESTED. AS THE CUSTOMER COULD NOT PROVIDE THE CONCERNED STRAINS AND STRIPS, NO FURTHER INVESTIGATION COULD BE PERFORM. NO ROOT CAUSE CAN BE DETERMINED WITH THE INVESTIGATION PERFORMED. THE PERFORMANCE OF THE LOT IS WITHIN SPECIFICATIONS AND THE INVESTIGATION DID NOT CONFIRM THE ISSUE OBSERVED BY THE CUSTOMER.