CHROMID CPS ELITE 20 PLT TRANS - 418284

Additional Manufacturer Narrative

AN INVESTIGATION WAS INITIATED IN RELATION TO A FALSE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE STRAIN ON CHROMID® CPS® ELITE AGAR (CPSE) REFERENCE (B)(4), LOT 1010059790 (EXPIRATION DATE 24-SEPTEMBER-2023). THE COLONIES WERE PINK ON THE PLATE, LEADING TO AN IDENTIFICATION OF ESCHERICHIA COLI, BUT THE IDENTIFICATION PERFORMED ON BRUKER RESULTED IN AN IDENTIFICATION OF KLEBSIELLA PNEUMONIAE. DURING THE TROUBLESHOOTING, LOCAL CUSTOMER SERVICE IDENTIFIED OFF LABEL USE OF THE INCUBATION OF THE PLATES AT 35°C WITH CO2, AND USE OF THE AGAR FOR UROGENITAL SWAB. ACCORDING TO THE PACKAGE INSERT, ¿THE MEDIUM IS INOCULATED DIRECTLY WITH URINE¿. FURTHERMORE, THE INCUBATION OF THE STRAINS IS IN AEROBIC CONDITIONS CONCLUSION AN OFF-LABEL USE OF THE PRODUCT WAS IDENTIFIED, RELATED TO INCORRECT SAMPLE TESTED AND INCORRECT INCUBATION CONDITION. ACCORDING TO THE PACKAGE INSERT, CHROMID® CPS® ELITE AGAR IS A MEDIUM FOR ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THUS, THE MEDIUM IS INOCULATED DIRECTLY WITH URINE. THE INCUBATION OF THE PLATES IS REALIZED IN AEROBIC CONDITION, AT 35°C +/- 2°C, AND THE PLATES ARE EXAMINED AFTER 18 TO 24 HOURS OF INCUBATION. AS THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT PERFORMANCE ISSUE, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED.

Description of Event or Problem

INTENDED USE: ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THIS MEDIUM IS AN ISOLATION, ENUMERATION, AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THIS MEDIUM ENABLES: ¿ THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. ¿ THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI. ¿ THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA: ENTEROCOCCUS; KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC); PROTEUS, MORGANELLA, PROVIDENCIA (PMP) ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE ASSOCIATED WITH CHROMID CPS ELITE 20 PLT TRANS- REF. (B)(4), LOT 1010059790 WHICH LED TO A DELAY IN PATIENT TREATMENT. THE CUSTOMER IDENTIFIED PINK COLONIES ON THE CHROMID CPS 20 PLATES AND PERFORMED BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. THE CUSTOMER INDICATED THAT THE ISOLATE WAS TRANSPLANTED AND TESTED MULTIPLE TIMES WITH CONSISTENT PINK GROWTH ON CHROMID CPS 20 PLATES. THE CUSTOMER INDICATED THAT THIS EVENT LED TO A DELAY IN PATIENT TREATMENT AS THE PINK RESULT ON CHROMID CPS ELITE 20 PLT TRANS WAS USED TO SELECT ESCHERICHIA COLI DURING SUSCEPTIBILITY TESTING WITH VITEK 2 RESULTING IN INCONSISTENT RESULTS. THE ISOLATE WAS THEN TESTED USING BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE AND RETESTED USING VITEK 2 WITH CONSISTENT RESULTS. AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

Additional Manufacturer Narrative

AN INVESTIGATION WAS INITIATED IN RELATION TO A FALSE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE STRAIN ON CHROMID® CPS® ELITE AGAR (CPSE) REFERENCE (B)(4), LOT 1010059790 (EXPIRATION DATE 24-SEPTEMBER-2023). THE COLONIES WERE PINK ON THE PLATE, LEADING TO AN IDENTIFICATION OF ESCHERICHIA COLI, BUT THE IDENTIFICATION PERFORMED ON BRUKER RESULTED IN AN IDENTIFICATION OF KLEBSIELLA PNEUMONIAE. DURING THE TROUBLESHOOTING, LOCAL CUSTOMER SERVICE IDENTIFIED OFF-LABEL USE OF THE INCUBATION OF THE PLATES AT 35°C WITH CO2, AND USE OF THE AGAR FOR UROGENITAL SWAB. ACCORDING TO THE PACKAGE INSERT, ¿THE MEDIUM IS INOCULATED DIRECTLY WITH URINE¿. FURTHERMORE, THE INCUBATION OF THE STRAINS IS IN AEROBIC CONDITIONS. CONCLUSION AN OFF-LABEL USE OF THE PRODUCT WAS IDENTIFIED, RELATED TO INCORRECT SAMPLE TESTED AND INCORRECT INCUBATION CONDITION. ACCORDING TO THE PACKAGE INSERT, CHROMID® CPS® ELITE AGAR IS A MEDIUM FOR ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THUS, THE MEDIUM IS INOCULATED DIRECTLY WITH URINE. THE INCUBATION OF THE PLATES WAS REALIZED IN AEROBIC CONDITION, AT 35°C +/- 2°C, AND THE PLATES WERE EXAMINED AFTER 18 TO 24 HOURS OF INCUBATION. AS THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT PERFORMANCE ISSUE, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED.

Description of Event or Problem

INTENDED USE: ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THIS MEDIUM IS AN ISOLATION, ENUMERATION, AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THIS MEDIUM ENABLES: THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI. THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA: ENTEROCOCCUS; KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC); PROTEUS, MORGANELLA, PROVIDENCIA (PMP). ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE ASSOCIATED WITH CHROMID CPS ELITE 20 PLT TRANS- REF. (B)(4), LOT 1010059790 WHICH LED TO A DELAY IN PATIENT TREATMENT. THE CUSTOMER IDENTIFIED PINK COLONIES ON THE CHROMID CPS 20 PLATES AND PERFORMED BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. THE CUSTOMER INDICATED THAT THE ISOLATE WAS TRANSPLANTED AND TESTED MULTIPLE TIMES WITH CONSISTENT PINK GROWTH ON CHROMID CPS 20 PLATES. THE CUSTOMER INDICATED THAT THIS EVENT LED TO A DELAY IN PATIENT TREATMENT AS THE PINK RESULT ON CHROMID CPS ELITE 20 PLT TRANS WAS USED TO SELECT ESCHERICHIA COLI DURING SUSCEPTIBILITY TESTING WITH VITEK 2 RESULTING IN INCONSISTENT RESULTS. THE ISOLATE WAS THEN TESTED USING BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE AND RETESTED USING VITEK 2 WITH CONSISTENT RESULTS. AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

Description of Event or Problem

INTENDED USE: ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THIS MEDIUM IS AN ISOLATION, ENUMERATION, AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THIS MEDIUM ENABLES: THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI. THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA: ENTEROCOCCUS; KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC); PROTEUS, MORGANELLA, PROVIDENCIA (PMP). ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE ASSOCIATED WITH CHROMID CPS ELITE 20 PLT TRANS- REF. (B)(4), LOT 1010059790 WHICH LED TO A DELAY IN PATIENT TREATMENT. THE CUSTOMER IDENTIFIED PINK COLONIES ON THE CHROMID CPS 20 PLATES AND PERFORMED BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. THE CUSTOMER INDICATED THAT THE ISOLATE WAS TRANSPLANTED AND TESTED MULTIPLE TIMES WITH CONSISTENT PINK GROWTH ON CHROMID CPS 20 PLATES. THE CUSTOMER INDICATED THAT THIS EVENT LED TO A DELAY IN PATIENT TREATMENT AS THE PINK RESULT ON CHROMID CPS ELITE 20 PLT TRANS WAS USED TO SELECT ESCHERICHIA COLI DURING SUSCEPTIBILITY TESTING WITH VITEK 2 RESULTING IN INCONSISTENT RESULTS. THE ISOLATE WAS THEN TESTED USING BRUKER MASS SPECTROMETRY TO CONFIRM THE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE AND RETESTED USING VITEK 2 WITH CONSISTENT RESULTS. AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.