CHROMID® CPS® Elite Agar (CPSE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03573026600389), received between Nov 30, 2017 and Dec 2, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025False Negative Result; False Negative Result

  PRODUCT DESCRIPTION; 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). COMPLAINT DESCRIPTION: A CUSTOMER IN (B)(6) COMPLAINED AFTER HAVING OBTAINED UNCHARACTERISTIC COLOR COLONY OF KLEBSIELLA PNEUMONIAE WHEN USING CHROMID CPS ELITE 20 PLT TRANS -REFERENCE (B)(4). THE CUSTOMER SAID THAT THEY HAD INOCULATED A MICROOGANISM ISOLATED FROM A PATIENT'S SAMPLE ON THE MEDIUM CHROMID CPS ELITE 20 PLT TRANS LOT 1011518800 AGAR PLATE AND THAT AFTER INCUBATION THEY HAD OBSERVED A BACTERIAL GROWTH WITH PINK COLONIES WHICH IS NOT THE CHARACTERISTIC COLOR OF KLEBSIELLA PNEUMONIAE. THE CUSTOMER MENTIONED THAT THEY HAD PROCEEDED WITH FURTHER TESTING TO IDENTIFY THE STRAIN. THE CUSTOMER SAID THAT THET HAD PERFORMED MASS SPECTROMETRY TEST FOR THE SAMPLE THAT CONFIRMED THE STRAIN TO BE KLEBSIELLA PNEUMONIAE. AS INDICATED IN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694542 ↗
• MalfunctionNov 20, 2025False Negative Result; False Negative Result

  INTENDED USE 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). DESCRIPTION OF THE ISSUE: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF HAVING OBTAINED A FALSE NEGATIVE RESULT DUE TO A NON-CHARACTERISTIC COLORATION OF THE KLEBSIELLA PNEUMONIAE WITH THE CHROMID CPS ELITE 100 PL TRANS - REFERENCE 416172 ( LOT#1011514310). THE CUSTOMER STATED THAT HE HAD OBTAINED A KLEBSIELLA PNEUMONIAE STRAIN WITH PINK COLOR . THE CUSTOMER INDICATES HAVING PERFORMED A MASS SPECTROMETRY WHICH GAVE AN IDENTIFICATION OF KLEBSIELLA PNEUMONIAE. NOTE: CHROMID CPS ELITE HAS BEEN DESIGNED FOR THE PRESUMPTIVE IDENTIFICATION TO GROUP OR GENUS LEVEL. SMALL TURQUOISE OR PALE BLUE TO GREEN COLONIES: GENUS ENTEROCOCCUS. BLUE TO GREEN COLONIES: KESC GROUP (KLEBSIELLA, ENTEROBACTER, SERRATIA AND CITROBACTER) DIFFUSE BROWN COLONIES OR COLONIES W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605684 ↗
• MalfunctionAug 14, 2023False Negative Result; False Negative Result

  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 PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541125 ↗
• MalfunctionMar 13, 2023False Negative Result; False Negative Result

  INTENDED USE: CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. IT ENABLES: THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI AND THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA : ENTEROCOCCUS, KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC), PROTEUS, PROVIDENCIA, MORGANELLA (PROTEEAE). ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULT (NO GROWTH) WITH FUNGI STRAIN FROM PATIENT URINE SAMPLE IN ASSOCIATION WITH CHROMID CPS ELITE 20 PLT TRANS (REF. (B)(4), LOT 1009788140, EXP DATE. 4/25/2023) THE CUSTOMER STATED THAT HE HAD DISCREPANT RESULTS BETWEEN: THE CULTURE ON CHROM ID CPSE AND THE CHEMICAL-PHYSICAL EXAMINATION OF THE URINE SAMPLES COLLECTION FOR AN URINE CULTURE SAMPLE. RESULT SUMMARY: THE CULTURE ON CHROM ID CPSE PLATE: NO GROWTH; CHEMICAL-PHYSICAL EXAMINATION : PRESENCE OF FUNGI. THE CONDITIONS OF CONSERVATION AND USE OF THE MEDIA HAVE BEEN ADEQUATELY RESPECTED FROM THE CUSTOMER. UNTIL NOW , THE CUSTOMER HAS NOT USED SABOURAUD GENTAMICIN CHLORAMPHENICOL IN PARALLEL OF CHROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528777 ↗
• MalfunctionAug 18, 2022False Negative Result; False Negative Result

  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). DESCRIPTION: A CUSTOMER IN COLOMBIA NOTIFIED BIOMÉRIEUX OF OBTAINING INCORRECT COLONY COLORATION FOR ESCHERICHIA COLI IN ASSOCIATION WITH THE CHROMID® CPS ELITE 20 PLT TRANS (REF 418284, LOT 1009311370). THE CUSTOMER PROVIDED PHOTOS OF WHAT APPEARS TO BE BLUE/GREEN COLONIES, WHILE ESCHERICHIA COLI SHOULD PRODUCE RED TO BURGUNDY COLONIES. 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. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249144 ↗
• MalfunctionMar 21, 2022Contamination; Contamination

  INTENDED USE: CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MICROBIAL CONTAMINATION IN ASSOCIATION WITH THE CHROMID® CPS® ELITE AGAR (REF. (B)(4), LOT 1009188590). THE CUSTOMER OBSERVED MICROBIAL CONTAMINATION OF LARGE GLOSSY BEIGE COLONIES ON LOT 1009188590. THE CONTAMINANT WAS IDENTIFIED AS BACILLUS CEREUS USING THE VITEK® MS. THE CUSTOMER CONFIRMED TWO (2) CONTAMINATED PLATES WERE USED TO CULTURE URINE ISOLATES FROM TWO SEPARATE PATIENTS. THE CUSTOMER STATED THE OBSERVED CONTAMINATION CAUSED A DELAY OF TWENTY-FOUR HOURS AS NEW SUBCULTURE WAS REQUIRED. HOWEVER, THE CUSTOMER ADVISED THERE IS NO ADVERSE EVENT TO EITHER PATIENT'S STATE OF HEALTH; FINAL SUBCULTURE RESULTS WERE NEGATIVE FOR BOTH PATIENTS. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839675 ↗
• MalfunctionMar 21, 2022Contamination; Contamination

  INTENDED USE: CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF MICROBIAL CONTAMINATION IN ASSOCIATION WITH THE CHROMID® CPS® ELITE AGAR (REF. 416172, LOT 1009188590). THE CUSTOMER OBSERVED MICROBIAL CONTAMINATION OF LARGE GLOSSY BEIGE COLONIES ON LOT 1009188590. THE CONTAMINANT WAS IDENTIFIED AS BACILLUS CEREUS USING THE VITEK® MS. THE CUSTOMER CONFIRMED TWO (2) CONTAMINATED PLATES WERE USED TO CULTURE URINE ISOLATES FROM TWO SEPARATE PATIENTS. THE CUSTOMER STATED THE OBSERVED CONTAMINATION CAUSED A DELAY OF TWENTY-FOUR HOURS AS NEW SUBCULTURE WAS REQUIRED. HOWEVER, THE CUSTOMER ADVISED THERE IS NO ADVERSE EVENT TO EITHER PATIENT'S STATE OF HEALTH; FINAL SUBCULTURE RESULTS WERE NEGATIVE FOR BOTH PATIENTS. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839666 ↗
• MalfunctionSep 24, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INTENDED USE: CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF MICROBIAL CONTAMINATION IN ASSOCIATION WITH THE CHROMID® CPS® ELITE AGAR (REF. 416172, LOT 1008840600). THE CUSTOMER OBSERVED MICROBIAL CONTAMINATION OF LARGE GLOSSY BEIGE COLONIES ON LOT 1008840600. THE CONTAMINANT WAS IDENTIFIED AS ACINETOBACTER NOSOCOMIALIS USING THE MALDI-TOF TEST METHOD. THE CUSTOMER CONFIRMED TWO (2) CONTAMINATED PLATES WERE USED TO CULTURE URINE ISOLATES FROM TWO SEPARATE PATIENTS. THERE IS NO ADVERSE EVENT TO EITHER PATIENT'S STATE OF HEALTH; IT WAS CONFIRMED THE CONTAMINANT WAS OBSERVED AND NEW URINE SUBCULTURES WERE PERFORMED. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527598 ↗
• MalfunctionNov 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ON (B)(6) 2020 A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED LOW/NO GROWTH WHEN GROWING (B)(6) SAPROPHYTICUS ON CHROMID® CPS ELITE (CPSE) AGAR (REF. 418284; LOT 1008224360). THE CUSTOMER STATED HE INOCULATED A URINE SPECIMEN ON BOTH CPSE AGAR AND COLUMBIA AGAR + 5% SHEEP BLOOD (COS). GOOD GROWTH WAS OBSERVED ON THE COS AGAR. S. SAPROPHYTICUS WAS FURTHER CONFIRMED BY VITEK® MS WITH 99.9%. ON CPSE AGAR, NO S. SAPROPHYTICUS GROWTH WAS OBSERVED. THE CUSTOMER SUB-CULTURED THE SPECIMEN FROM THE COS PLATE TO CPSE AGAR AND COS AGAR, AND THE NEXT DAY OBSERVED GOOD GROWTH OF S. SAPROPHYTICUS (IDENTIFIED BY VITEK® MS WITH 99.9%) ON COS AGAR AND VERY LOW GROWTH ON THE CPSE AGAR. THE CUSTOMER STATED THAT ATCC® 15305¿ (S. SAPROPHYTICUS) AND OTHER SUGGESTED ATCC STRAINS WERE VERIFIED ON THIS BATCH OF AGAR. ALL ATCC PERFORMED WELL AND ATCC 15305 HAD GOOD GROWTH ON THIS CPSE AGAR. AS INDICATED IN THE INSTRUCTION FOR USE, SECTION LIMITATIONS OF THE METHOD: ¿GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICROORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS WHICH HAVE SPE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10820964 ↗
• MalfunctionNov 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. ON (B)(6) 2020 A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED LOW/NO GROWTH WHEN GROWING STAPHYLOCOCCUS SAPROPHYTICUS ON CHROMID® CPS ELITE (CPSE) AGAR (REF. 418284; LOT 1008219350). THE CUSTOMER STATED HE INOCULATED A URINE SPECIMEN ON BOTH CPSE AGAR AND COLUMBIA AGAR + 5% SHEEP BLOOD (COS). GOOD GROWTH WAS OBSERVED ON THE COS AGAR. S. SAPROPHYTICUS WAS FURTHER CONFIRMED BY VITEK® MS WITH 99.9%. ON CPSE AGAR, NO S. SAPROPHYTICUS GROWTH WAS OBSERVED. THE CUSTOMER SUB-CULTURED THE SPECIMEN FROM THE COS PLATE TO CPSE AGAR AND COS AGAR, AND THE NEXT DAY OBSERVED GOOD GROWTH OF S. SAPROPHYTICUS (IDENTIFIED BY VITEK® MS WITH 99.9%) ON COS AGAR AND VERY LOW GROWTH ON THE CPSE AGAR. THE CUSTOMER STATED THAT ATCC® 15305¿ (S. SAPROPHYTICUS) AND OTHER SUGGESTED ATCC STRAINS WERE VERIFIED ON THIS BATCH OF AGAR. ALL ATCC PERFORMED WELL AND ATCC 15305 HAD GOOD GROWTH ON THIS CPSE AGAR. AS INDICATED IN THE INSTRUCTION FOR USE, SECTION LIMITATIONS OF THE METHOD: ¿GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICROORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS WHICH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10820956 ↗
• MalfunctionOct 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT: 1008224320) WHILE TESTING FOUR SEPARATE PATIENT SAMPLES. THE CUSTOMER CULTURED THREE (3) SEPARATE URINE ISOLATES AND ONE (1) SUBPHRENIC PUNCTURE FLUID ISOLATE USING LOT: 1008224320. BIOMERIEUX CUSTOMER SERVICE ADVISED THAT CHROMID® CPS ELITE 100 PL TRANS REF. 416172 IS FOR VALIDATED THE TESTING OF URINE SAMPLES ONLY AND THAT TESTING OF OTHER SAMPLE TYPES IS CONSIDERED OFF LABEL USE. THE ISOLATES WERE THEN TESTED USING THE VITEK® MS; ALL ISOLATES WERE IDENTIFIED AS ACINETOBACTER NOSOCOMIALIS. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS ATYPICAL. ADDITIONALLY, THE CUSTOMER STATED THEIR PREVI® ISOLA COMB TRACED A CONTAMINANT ON THE PERIMETER OF THE THREE URINE ISOLATE PLATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10687625 ↗
• MalfunctionOct 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 1008224320) WHILE TESTING FOUR SEPARATE PATIENT SAMPLES. THE CUSTOMER CULTURED THREE (3) SEPARATE URINE ISOLATES AND ONE (1) SUBPHRENIC PUNCTURE FLUID ISOLATE USING LOT 1008224320. BIOMERIEUX CUSTOMER SERVICE ADVISED CHROMID® CPS ELITE 100 PL TRANS REF. 416172 IS VALIDATED FOR THE TESTING OF URINE SAMPLES ONLY AND THAT TESTING OF OTHER SAMPLE TYPES IS CONSIDERED OFF LABEL USE. THE ISOLATES WERE THEN TESTED USING THE VITEK® MS; ALL ISOLATES WERE IDENTIFIED AS ACINETOBACTER NOSOCOMIALIS. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS ATYPICAL. ADDITIONALLY, THE CUSTOMER STATED THEIR PREVI® ISOLA COMB TRACED A CONTAMINANT ON THE PERIMETER OF THE THREE URINE ISOLATE PLATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10687619 ↗
• MalfunctionOct 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 41008224320) WHILE TESTING FOUR SEPARATE PATIENT SAMPLES. THE CUSTOMER CULTURED THREE (3) SEPARATE URINE ISOLATES AND ONE (1) SUBPHRENIC PUNCTURE FLUID ISOLATE USING LOT 1008224320 BIOMERIEUX CUSTOMER SERVICE ADVISED CHROMID® CPS ELITE 100 PL TRANS REF. 416172 IS VALIDATED FOR THE TESTING OF URINE SAMPLES ONLY AND THAT TESTING OF OTHER SAMPLE TYPES IS CONSIDERED OFF LABEL USE. THE ISOLATES WERE THEN TESTED USING THE VITEK® MS; ALL ISOLATES WERE IDENTIFIED AS ACINETOBACTER NOSOCOMIALIS. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS ATYPICAL. ADDITIONALLY, THE CUSTOMER STATED THEIR PREVI® ISOLA COMB TRACED A CONTAMINANT ON THE PERIMETER OF THE THREE URINE ISOLATE PLATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10687599 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 1008224320). THE CUSTOMER RECEIVED A TOTAL OF FIFTEEN KITS OF 100 PLATES EACH OF LOT 1008224320; TOTAL OF ONE HUNDRED FIFTY (150) AGAR PLATES WERE IDENTIFIED AS CONTAMINATED. THE CUSTOMER STATED FOUR (4) PATIENT URINE SAMPLES WERE TESTED USING THE CONTAMINATED PLATES. AGAR PLATES FROM TWO PATIENTS OBTAINED A RESULT OF ACINETOBACTER NOSOCOMIALIS ONLY; AGAR PLATES FROM THE OTHER TWO PATIENT SAMPLES OBTAINED RESULTS OF ACINETOBACTER NOSOCOMIALIS AND ESCHERICHIA COLI. STERILITY TESTING WAS PERFORMED USING TEN (10) AGAR PLATES FROM LOT 1008224320, SIX OF THE TEN PLATES FAILED THE STERILITY TEST AND EXHIBITED GROWTH. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678482 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 1008224320). THE CUSTOMER RECEIVED A TOTAL OF FIFTEEN KITS OF 100 PLATES EACH OF LOT 1008224320; TOTAL OF ONE HUNDRED FIFTY (150) AGAR PLATES WERE IDENTIFIED AS CONTAMINATED. THE CUSTOMER STATED FOUR (4) PATIENT URINE SAMPLES WERE TESTED USING THE CONTAMINATED PLATES. AGAR PLATES FROM TWO PATIENTS OBTAINED A RESULT OF ACINETOBACTER NOSOCOMIALIS ONLY; AGAR PLATES FROM THE OTHER TWO PATIENT SAMPLES OBTAINED RESULTS OF ACINETOBACTER NOSOCOMIALIS AND ESCHERICHIA COLI. STERILITY TESTING WAS PERFORMED USING TEN (10) AGAR PLATES FROM LOT 1008224320, SIX OF THE TEN PLATES FAILED THE STERILITY TEST AND EXHIBITED GROWTH. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678284 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 1008224320). THE CUSTOMER RECEIVED A TOTAL OF FIFTEEN KITS OF 100 PLATES EACH OF LOT 1008224320; TOTAL OF ONE HUNDRED FIFTY (150) AGAR PLATES WERE IDENTIFIED AS CONTAMINATED. THE CUSTOMER STATED FOUR PATIENT URINE SAMPLES WERE TESTED USING THE CONTAMINATED PLATES. AGAR PLATES FROM TWO PATIENTS OBTAINED A RESULT OF ACINETOBACTER NOSOCOMIALIS ONLY; AGAR PLATES FROM THE OTHER TWO PATIENT SAMPLES OBTAINED RESULTS OF ACINETOBACTER NOSOCOMIALIS AND ESCHERICHIA COLI. STERILITY TESTING WAS PERFORMED USING TEN (10) AGAR PLATES FROM LOT 1008224320, SIX OF THE TEN PLATES FAILED THE STERILITY TEST AND EXHIBITED GROWTH. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678267 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CONTAMINATION WITH ACINETOBACTER NOSOCOMIALIS IN ASSOCIATION WITH CHROMID® CPS ELITE 100 PL TRANS (REF. 416172, LOT 1008224320). THE CUSTOMER RECEIVED A TOTAL OF FIFTEEN KITS OF 100 PLATES EACH OF LOT 1008224320; TOTAL OF ONE HUNDRED FIFTY (150) AGAR PLATES WERE IDENTIFIED AS CONTAMINATED. THE CUSTOMER STATED FOUR (4) PATIENT URINE SAMPLES WERE TESTED USING THE CONTAMINATED PLATES. AGAR PLATES FROM TWO PATIENTS OBTAINED A RESULT OF ACINETOBACTER NOSOCOMIALIS ONLY; AGAR PLATES FROM THE OTHER TWO PATIENT SAMPLES OBTAINED RESULTS OF ACINETOBACTER NOSOCOMIALIS AND ESCHERICHIA COLI. STERILITY TESTING WAS PERFORMED USING TEN (10) AGAR PLATES FROM LOT 1008224320, SIX OF THE TEN PLATES FAILED THE STERILITY TEST AND EXHIBITED GROWTH. THE CUSTOMER STATED THE RESULT OF ACINETOBACTER NOSOCOMIALIS WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678248 ↗
• MalfunctionMar 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A CONTAMINATION AFTER USE IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (REF. 416172, LOT 1007747790) WHEN TESTING TWO SEPARATE PATIENT URINE SAMPLES. THE CUSTOMER OBSERVED CONTAMINATION ON THIRTY (30) PLATES FROM FOUR (4) BOXES OF LOT 1007747790. THE CUSTOMER NOTED TWO CONTAMINATED PLATES HAD ALREADY BEEN USED TO TEST TWO (2) SEPARATE PATIENT URINE SAMPLES. THE CONTAMINATION WAS OBSERVED AFTER INCUBATION. THE CONTAMINANT ON BOTH PLATES WAS A LARGE CREAM-COLORED MUCOUS COLONY; BRUCKER MALDI-TOF IDENTIFIED THE CONTAMINANT AS PSEUDOMONAS. THE CUSTOMER CONFIRMED BOTH CONTAMINATED PATIENT SAMPLE PLATES WERE DISCARDED AND THE RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788852 ↗
• MalfunctionMar 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A CONTAMINATION AFTER USE IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (REF. 416172, LOT 1007747790) WHEN TESTING TWO SEPARATE PATIENT URINE SAMPLES. THE CUSTOMER OBSERVED CONTAMINATION ON THIRTY (30) PLATES FROM FOUR (4) BOXES OF LOT 1007747790. THE CUSTOMER NOTED TWO CONTAMINATED PLATES HAD ALREADY BEEN USED TO TEST TWO (2) SEPARATE PATIENT URINE SAMPLES. THE CONTAMINATION WAS OBSERVED AFTER INCUBATION. THE CONTAMINANT ON BOTH PLATES WAS A LARGE CREAM-COLORED MUCOUS COLONY; BRUCKER MALDI-TOF IDENTIFIED THE CONTAMINANT AS PSEUDOMONAS. THE CUSTOMER CONFIRMED BOTH CONTAMINATED PATIENT SAMPLE PLATES WERE DISCARDED AND THE RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788781 ↗
• MalfunctionMar 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF NO/LOW GROWTH ON CHROMID® CPS ELITE 100 PL TRANS (REF 416172 LOT 1007755860) FOR A PATIENT URINE SPECIMEN. THE CUSTOMER REPORTED THAT THE SAMPLE FROM THE PATIENT WAS TESTED IN PARALLEL ON THE CHROMID® CPS AGAR AND BLOOD AGAR. THE CUSTOMER COULD OBSERVE MANY COLONIES ON THE BLOOD AGAR AND VERY FEW OR NONE ON THE CHRMID® CPS AGAR. THE CUSTOMER ALSO OBSERVED THAT THE CHROMID® CPS AGAR PLATE AREA WAS NOT FLAT AND HOMOGENOUS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787644 ↗
• MalfunctionMar 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF NO/LOW GROWTH ON CHROMID® CPS ELITE 100 PL TRANS (REF 416172 LOT 1007755860) FOR A PATIENT URINE SPECIMEN. THE CUSTOMER REPORTED THAT THE SAMPLE FROM THE PATIENT WAS TESTED IN PARALLEL ON THE CHROMID® CPS AGAR AND BLOOD AGAR. THE CUSTOMER COULD OBSERVE MANY COLONIES ON THE BLOOD AGAR AND VERY FEW OR NONE ON THE CHRMID® CPS AGAR. THE CUSTOMER ALSO OBSERVED THAT THE CHROMID® CPS AGAR PLATE AREA WAS NOT FLAT AND HOMOGENOUS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787596 ↗
• MalfunctionNov 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS (LOW GROWTH / NO GROWTH / NO COLOR) IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (REF. 418284, LOT 1007515320). THE CUSTOMER STATED SHE OBSERVED THIS BEHAVIOR WHEN THE CORRESPONDING URINE CULTURE IS POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN CONDUCTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9312090 ↗
• MalfunctionJul 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT WHEN TESTING A LECLERCIA ADECARBOXYLATA STRAIN FROM AN EEQ BIOLOGY PROSPECTIVE SURVEY (EBU 201- URINE SAMPLE) ON CHROMID® CPS ELITE (REF. 416172, LOT. #1007250760, EXP.DATE: 30-JUL-2019). CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THE CUSTOMER STATED THAT WHEN TESTING THIS EEQ LECLERCIA ADECARBOXYLATA STRAIN FROM A 10 L DEPOSIT, HE OBTAINED ONLY 1,000 UNITS/ML WHILE THE EXPECTED NUMBER OF COLONIES WAS 10,000 TO 1,000,000/ML. THE COLLECTION IS PERFORMED MANUALLY FROM A 10 L DEPOSIT USING A CALIBRATED LOOP UNTIL EXHAUSTION. THE CUSTOMER PERFORMED A RETEST AND OBTAINED THE SAME RESULTS ON ANOTHER PLATE FROM THE SAME LOT. #1007250760. THE CUSTOMER ALSO STATED THAT HE USED THIS LOT TO TEST PATIENT SAMPLES, AND THAT HE DID NOT OBSERVE ANY ANOMALIES. THE IMPACTED LOT WAS TESTED WITH ATCC 25922 E.COLI STRAIN AND THE CUSTOMER OBTAINED SMALL BURGUNDY COLONIES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE IS NO PATIENT DIRECTLY ASSOCIATED WITH THE EEQ SAMPLE. A B

  Patient problems: No Patient Involvement

  MAUDE report 8812743 ↗
• MalfunctionMar 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED NO GROWTH (FALSE NEGATIVE) OF AN ESCHERICHIA COLI STRAIN FROM A PATIENT URINE SAMPLE, IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (LOT 1007058530). THE SAMPLE WAS FROM A (B)(6) YEAR OLD PATIENT WITH NO ANTIBIOTIC THERAPY AND INFLAMMATORY SYNDROME AND LEUKOCYTOSIS. THE CUSTOMER STATED THERE WAS NO GROWTH ON THE CHROMID CPS ELITE AGAR, BUT GROWTH WAS OBSERVED ON COS + POLYVITEX AGAR. THE STRAIN WAS THEN IDENTIFIED AS ESCHERICHIA COLI BY VITEK® 2. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458030 ↗
• MalfunctionNov 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) REPORTED A NO RESULT (NO GROWTH) FOR AN EXTERNAL QUALITY CONTROL (EQA) SAMPLE (NEQAS DISTRIBUTION 4341 SAMPLE 4569) ON CHROMID® CPS ELITE AGAR (LOT 1006606560). THE EXPECTED RESULT OF THE EQA SAMPLE WAS STAPHYLOCOCCUS SAPROPHYTICUS. WHEN THE CUSTOMER OBTAINED THE RESULTS OF THE NEQAS SURVEY, THEY ASKED FOR A REPEAT SAMPLE. THE CUSTOMER THEN TESTED A SECOND LOT (100666680) OF CHROMID CPS ELITE, AND ALSO CULTURED THE EQA SAMPLE ONTO BLOOD AGAR AND CLED (CYSTINE LACTOSE ELECTROLYTE DEFICIENT) MEDIUM. THE RESULT WAS NO GROWTH ON CHROMID CPS ELITE, WHILE STAPHYLOCOCCUS SAPROPHYTICUS GREW ON BOTH BLOOD AGAR AND CLED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8062054 ↗