VITEK® MS PRIME 423281Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03573026611422), received between Mar 23, 2022 and Aug 8, 2024 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM AND THIS MANUAL ARE INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. ISSUE DESCRIPTION: A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED MISIDENTIFICATIONS OF THREE (3) STRAINS (EACH FROM A DIFFERENT PATIENT) AS BRUCELLA SPECIES IN ASSOCIATION WITH THE VITEK® MS PRIME (REF 423281, SERIAL (B)(6)). THE CUSTOMER REPORTED THAT THEY OBTAINED IDENTIFICATIONS OF BRUCELLA SPECIES FOR EACH STRAIN WITH THE VITEK MS PRIME, BUT GRAM-STAINING, COLONY MORPHOLOGY, AND BIOCHEMICAL REACTIONS DO NOT ALIGN WITH AN IDENTIFICATION OF BRUCELLA SPECIES. PATIENT 1: VITEK MS PRIME: BRUCELLA SPECIES 99.9%. EXPECTED: NOT BRUCELLA. PATIENT 2: VITEK MS PRIME: BRUCELLA SPECIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938759 ↗
• MalfunctionAug 8, 2024Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM AND THIS MANUAL ARE INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. ISSUE DESCRIPTION: A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED MISIDENTIFICATIONS OF THREE (3) STRAINS (EACH FROM A DIFFERENT PATIENT) AS BRUCELLA SPECIES IN ASSOCIATION WITH THE VITEK® MS PRIME (REF 423281, SERIAL (B)(6)). THE CUSTOMER REPORTED THAT THEY OBTAINED IDENTIFICATIONS OF BRUCELLA SPECIES FOR EACH STRAIN WITH THE VITEK MS PRIME, BUT GRAM-STAINING, COLONY MORPHOLOGY, AND BIOCHEMICAL REACTIONS DO NOT ALIGN WITH AN IDENTIFICATION OF BRUCELLA SPECIES. PATIENT 1: VITEK MS PRIME: BRUCELLA SPECIES 99.9% EXPECTED: NOT BRUCELLA PATIENT 2: VITEK MS PRIME: BRUCELLA SPECIES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938724 ↗
• MalfunctionAug 8, 2024Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM AND THIS MANUAL ARE INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. ISSUE DESCRIPTION: A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED MISIDENTIFICATIONS OF THREE (3) STRAINS (EACH FROM A DIFFERENT PATIENT) AS BRUCELLA SPECIES IN ASSOCIATION WITH THE VITEK® MS PRIME (REF 423281, SERIAL (B)(6). THE CUSTOMER REPORTED THAT THEY OBTAINED IDENTIFICATIONS OF BRUCELLA SPECIES FOR EACH STRAIN WITH THE VITEK MS PRIME, BUT GRAM-STAINING, COLONY MORPHOLOGY, AND BIOCHEMICAL REACTIONS DO NOT ALIGN WITH AN IDENTIFICATION OF BRUCELLA SPECIES. PATIENT 1: VITEK MS PRIME: BRUCELLA SPECIES 99.9% EXPECTED: NOT BRUCELLA PATIENT 2: VITEK MS PRIME: BRUCELLA SPECIES 8

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938721 ↗
• MalfunctionMar 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INTENDED USE THE VITEK® MS SYSTEMS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE A CUSTOMER IN BELGIUM NOTIFED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF AN UNKNOWN STRAIN AS BRUCELLA SPECIES WHEN USING THE VITEK MS PRIME - 423281( SERIAL NUMBER : (B)(6) ) SUMMARY 2 SAMPLES INITIAL TESTING - VITEK MS IDENTIFICATION BRUCELLA 99% ALTERNATE METHOD TESTING - PCR PCR NEGATIVE. FOR NOW, THE EXPECTED IDENTIFICATION IS UNKNOWN. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. BIOMÉRIEUX INTERNAL STANDARD OPERATIONAL PROCEDURES STATES THAT ERRONEOUS TEST RESULTS COULD RESULT IN A LACK OF APPROPRIATE DIAGNOSIS OR THERAPY, CONTINUED ADMINISTRATION OF INAPPROPRIATE ANTIMICROBIALS, OR OTHER POTENTIALLY TOXIC THERAPIES. THIS REVIEW HAS DETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835313 ↗
• MalfunctionOct 5, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE; THE VITEK® MS SYSTEMS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE; A CUSTOMER IN NETHERLANDS NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF PSEUDOMONAS SPECIES AS BRUCELLA SPECIES 99.9% WHEN USING THE VITEK MS PRIME (REFERENCE (B)(4), SERIAL NUMER (B)(6)). THE CUSTOMER INDICATED THAT THE EXPECTED IDENTIFICATION HAS BEEN CONFIRMED WITH A 16S SEQUENCING. SUMMARY: INITIAL TESTING - VITEK MS PRIME BRUCELLA SPECIES (99.9%) REPEAT TESTING - VITEK MS PRIME BRUCELLA SPECIES (94.6%) ALTERNATE METHOD TESTING - 16S SEQUENCING PSEUDOMONAS SPECIES. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875515 ↗
• MalfunctionJul 20, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM IS INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF A CORYNEBACTERIUM SPECIES AS BRUCELLA SPECIES IN ASSOCIATION WITH THE VITEK® MS PRIME (REF (B)(4), SERIAL (B)(6)). THE CUSTOMER REPORTED THAT THEY OBTAINED AN IDENTIFICATION OF BRUCELLA SPECIES WITH INITIAL TESTING USING THE VITEK MS PRIME. THE IDENTIFICATION TO BRUCELLA SPECIES WAS UNABLE TO BE REPRODUCED AND THE ORGANISM WAS CONFIRMED TO BE CORYNEBACTERIUM. VITEK MS PRIME: BRUCELLA SPECIES EXPECTED: CORYNEBACTERIUM SPECIES THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363684 ↗
• MalfunctionMay 2, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE REPORTED TO BIOMÉRIEUX POTENTIAL MISIDENTIFICATIONS OF STREPTOCOCCUS MITIS/ORALIS AS STREPTOCOCUS PNEUMONIAE, MORAXELLA CATARRHALIS AND ROTHIA MUCILAGINOSA WHILE USING VITEK MS PRIME (REF. 423281, SERIAL NUMBER UNKNOWN). IT WAS REPORTED THAT CUSTOMER RECEIVED NO IDENTIFICATION (ID) RESULTS AND MISIDENTIFICATIONS WITH FIVE (5) ISOLATES (NUMBERS H2362082-1 / -2 / -3 / -4 / -5) COMPARED TO VITEK 2 GP IDENTIFICATION AND OPTOCHIN TEST RESULTS. IT WAS CONFIRMED THAT THE FIVE (5) ISOLATES WERE FROM THE SAME PATIENT WHO WAS A 9 WEEK OLD CHILD WITH MEDICAL HISTORY OF PYELONEPHRITIS. THE RESULTS OBTAINED WITH VITEK MS PRIME (MENTIONED IN LAB REPORTS PROVIDED BY CUSTOMER) WERE AS FOLLOWS: ISOLATE H2362082-1: RESULTS VALIDAT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16852324 ↗
• MalfunctionApr 26, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION. VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM IS INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. COMPLAINT DESCRIPTION. A CUSTOMER IN THE UNITED KINGDOM COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS POTENTIAL INCORRECT IDENTIFICATION TEST RESULTS WHEN USING THEIR VITEK MS PRIME SYSTEM. THE CUSTOMER SAID THAT IN SOME INSTANCES THEY WERE UNABLE TO GET A CORRECT IDENTIFICATION TEST RESULT. THE CUSTOMER MENTIONED THEY HAD OBTAINED "NO IDENTIFICATION" TEST RESULTS IN MANY CASES. NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS ASSESSMENT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16813579 ↗
• MalfunctionMar 30, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM IS INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS A POTENTIAL INCORRECT IDENTIFICATION TEST RESULT. THE CUSTOMER SAID THAT THEY HAD TESTED A MICROORGANISM USING THEIR VITEK MS PRIME SYSTEM AND THAT IT WAS IDENTIFIED AS STREPTOCOCCUS PNEUMONIAE. THE CUSTOMER STATES THAT THE IDENTIFICATION RESULT IS INCORRECT. NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS ASSESSMENT. THE CUSTOMER VITEK MS PRIME DATA WERE REPROCESSED BY BIOMÉRIEUX GLOBAL CUSTOMER SERVICE (GCS). BASED ON PRELIMINARY FINDINGS, THE ORGANISM COULD BE A STREPTOCOCCUS INFAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644753 ↗
• MalfunctionMar 30, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS.THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS.THE VITEK® MS PRIME SYSTEM IS INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. DESCRIPTION OF THE ISSUE. A CUSTOMER IN PORTUGAL NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF STREPTOCOCCUS MITIS/ORALIS AS STREPTOCOCCUS PNEUMONIAE WHEN TESTING A PEDIATRIC BLOOD SAMPLE USING THE VITEK MS PRIME -REFERENCE 423281 ( SERIAL NUMBER# (B)(4)). INDEED, THE CUSTOMER INDICATED THAT A SAMPLE FROM A PEDIATRIC BLOOD CULTURE HAD BEEN IDENTIFIED AS A STREPTOCOCCUS PNEUMONIAE BUT ALL THE OTHER METHODS AND DIAGNOSIS WERE INCONSISTENT WITH STREPTOCOCCUS PNEUMONIAE. SUMMARY: VITEK PRIME : STREPTOCOCCUS PNEUMONIAE VITEK 2 : STREP MITIS/ORALIS. OPTOQUINE : RESISTANT, THE AST PROFILE IS NOT CONSISTEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643831 ↗
• MalfunctionMar 23, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN PORTUGAL REPORTED TO BIOMÉRIEUX A POTENTIAL MISIDENTIFICATION OF STREPTOCOCCUS PYOGENES AS STREPTOCOCCUS PNEUMONIAE WHILE USING VITEK MS PRIME (REF: (B)(4). THE PATIENT IS A TWO-YEAR OLD BABY WITH A DIAGNOSIS OF AN INVASIVE DISEASE BY STREPTOCOCCUS PYOGENES AND WITH SEPTIC ARTHRITIS IN THE SHOULDER. IT WAS REPORTED THAT THE CUSTOMER DOESN¿T WANT TO SHARE MANY DETAILS, BUT IT SEEMS THAT THE STREPTOCOCCUS PYOGENES WAS ISOLATED FROM A SOFT TISSUE ON (B)(6) 2023. ON (B)(6) 2023 THEY TESTED ANOTHER SAMPLE (TYPE OF SAMPLE NOT REPORTED), AND THE STRAIN ISOLATED WAS STREPTOCOCCUS PYOGENES. THE URINE FROM ON (B)(6) 2023 WAS NEGATIVE. ON THE SAME DAY, THEY HAVE ALSO COLLECTED BLOOD CULTURE. THAT WAS FLAGGED AS POSITIVE ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596605 ↗
• MalfunctionMar 23, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN HUNGARY REPORTED TO BIOMÉRIEUX A POTENTIAL MISIDENTIFICATION AS BRUCELLA SPP. WHILE USING VITEK MS PRIME (REF. 423281, SERIAL NUMBER (B)(4)). IT WAS REPORTED THAT CUSTOMER RECEIVED A RESULT OF "NO IDENTIFICATION" RESULT IN CASE OF A STRAIN WHICH WAS REALLY ROUGH ON THE AGAR AND IT WAS DIFFICULT TO APPLY IT ONTO THE SLIDE SPOT. CUSTOMER PROVIDED BIOMÉRIEUX LOCAL CUSTOMER SERVICE WITH PICTURES OF THE CULTURE ON COLUMBIA BLOOD AGAR, TRYPTIC SOY AGAR AND SPOT IMAGES. CUSTOMER PERFORMED THE IDENTIFICATION EIGHT (8) TIMES, AND TWICE OBTAINED THE RESULT BRUCELLA WITH 93.8% AND 99.3% PROBABILITY. BACTERIA PROTOCOL WAS USED (ONLY MATRIX) AND COLONIES WERE TAKEN FROM TRYPTIC SOY AGAR. ACCORDING TO BIOMÉRIEUX GLOBAL CUSTOMER SERVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596497 ↗
• MalfunctionJan 3, 2023Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF CUTIBACTERIUM ACNES AS CUTIBACTERIUM AVIDUM. IN ASSOCIATION WITH THE VITEK® MS PRIME (B)(4). THE CUSTOMER REPORTED THAT THE INITIAL TESTING OF THE ISOLATE ON THE VITEK MS PRIME OBTAINED AN IDENTIFICATION OF CUTIBACTERIUM AVIDUM. WHILE REPEAT TESTING WITH THE VITEK MS PRIME AND TESTING ON THE LEGACY VITEK® MS INSTRUMENT OBTAINED IDENTIFICATIONS OF CUTIBACTERIUM ACNES. THE EXPECTED IDENTIFICATION WAS CUTIBACTERIUM ACNES. THE ISOLATE WAS SENT TO A REFERENCE LABORATORY WHERE IT WAS IDENTIFIED BY LEGACY VITEK MS AS CUTIBACTERIUM ACNES. CONVENTIONAL INDOLE TESTING WAS POSITIVE. THIS CONFIRMED C. ACNES AND RULED OUT C, AVIDUM. THE COLONY MORPHOLOGY ALSO DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092281 ↗
• MalfunctionDec 29, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. THE VITEK® MS PRIME SYSTEM AND THIS MANUAL ARE INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. DESCRIPTION: A CUSTOMER IN THE UNITED KINGDOM NOTIFIED (B)(6) OF OBTAINING A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS BRUCELLA SPP. WITH THE VITEK® MS PRIME (B)(4). THE CUSTOMER REPORTED THAT THE VITEK MS PRIME OBTAINED A RESULT OF BRUCELLA SPP (98.5%) WHILE THE ORGANISM WAS PHENOTYPICALLY NOT A BRUCELLA. THE ORGANISM GREW ON MACONKEY AGAR WITHIN 24 HOURS, TESTED OXIDASE NEGATIVE, AND MORPHOLOGY WAS LONG CAPSULATED BACILLI. A BRUKER MALDI-TOF WAS USED AS AN ALTERNATIVE IDENTIFICATION METHOD AND OBTAINED THE EXPECTED RESULT OF KLEBSIELLA PNEUMONIAE. THE CUSTOMER INDICATED THAT AN IDENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073520 ↗
• MalfunctionDec 21, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: THE VITEK® MS SYSTEM, REFERENCE (B)(4), IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN MALAYSIA NOTIFIED BIOMERIEUX OF OBTAINING DISCREPANT IDENTIFICATION RESULTS. BETWEEN VITEK MS PRIME REFERENCE (B)(4) ( SERIAL NUMBER : (B)(4)) AND VITEK MS LEGACY AND BETWEEN VITEK MS PRIME REFERENCE (B)(4) ( SERIAL NUMBER : (B)(4)) & VITEK 2 ( LOT NOT SPECIFIED). SUMMARY: ISOLATE 1. VITEK MS PRIME AEROMONAS SOBRIA/VERONII. VITEK MS LEGACY : AEROMONAS HYDROPHILA 99.9%. VITEK 2 GN :AEROMONAS HYDROPHILA 98%.. ISOLATE 2. VITEK MS PRIME AEROMONAS SOBRIA/VERONII. VITEK 2 AEROMONAS HYDROPHILA 98%. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. THIS DISCREPANCY WAS REVIEWED FOR VIGILANCE REPORTING ACCORDING TO 21 CFR 803 CONCERNING MEDICAL DEVICE REPORTING. BIOMÉRIEUX INTERNAL STANDARD OPERATIONAL PROCEDURES STATES THAT ERRONEOUS TEST RESULTS COULD RESULT IN A LACK OF A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022862 ↗
• MalfunctionDec 5, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN-VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN PORTUGAL NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF ESCHERICHIA COLI AS MOELLERELLA WISCONSENSIS IN ASSOCIATION WITH VITEK MS PRIME (REF. (B)(4), LOT ES00113). ALTERNATE METHOD TESTING WAS PERFORMED VIA VITEK 2 WITH RESULTS OF ESCHERICHIA COLI. REPEAT TESTING WAS PERFORMED ON VITEK MS PRIME WITH RESULTS OF ESCHERICHIA COLI. AT THE TIME OF 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 OR ANY DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917156 ↗
• MalfunctionNov 10, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOULD INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN SWEDEN NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF MICROCOCCUS SP AS BACILLUS CEREUS OR PSEUDOMONAS AERUGINOSA IN ASSOCIATION WITH THE VITEK MS PRIME REF. (B)(4), SERIAL NUMBER (B)(4). CUSTOMER HAS BEEN TESTING THEIR NEW VMS PRIME IN PARALLEL WITH BRUKER. THEY HAD GRAM POSITIVE COCCI FROM BLOOD CULTURE, WHICH WAS PROCESSED 2 X 3 SPOTS ON VMS PRIME. 1ST RUN: ONE ID AS BACILLUS CEREUS (61%) AND "NO ID" IN THE OTHER TWO SPOTS. SLIDE: DS220618609. 2ND RUN: ONE ID AS PSEUDOMONAS AERUGINOSA (83.1%) AND "NO ID" IN THE OTHER TWO SPOTS. SLIDE: DS220618609. BRUKER GAVE ID TO MICROCOCCUS SP., WHICH FITS THE CLINICAL DATA. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774166 ↗
• MalfunctionNov 10, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN SWEDEN NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF STAPHYLOCOCCUS HOMINIS AS CITROBACTER FREUNDII IN ASSOCIATION WITH THE VITEK MS PRIME (B)(4). CUSTOMER HAS BEEN TESTING THEIR NEW VMS PRIME IN PARALLEL WITH BRUKER. THEY HAD GRAM POSITIVE COCCI FROM BLOOD CULTURE, WHICH WAS IDENTIFIED AS CITROBACTER FREUNDII (93.7%) IN 1 OF 3 SPOTS, AND "NO ID" IN THE OTHER 2 SPOTS. SAMPLE NUMBER: (B)(6), SLIDE ID: (B)(6). BRUKER GAVE ID STAPHYLOCOCCUS HOMINIS, WHICH FITS THE CLINICAL DATA. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15773696 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE INCONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION AS BRUCELLA SPECIES WHEN USING VITEK MS PRIME INSTRUMENT (REF. 423281, SERIAL NUMBER: (B)(4). CUSTOMER INDICATED THAT DURING THE LAST WEEK, THEY RECEIVED TWO (2) IDENTIFICATIONS AS BRUCELLA WITH 80% AND 99% OF CONFIDENCE BUT NEITHER ISOLATE WAS ACTUALLY BRUCELLA. CUSTOMER INDICATED THAT TWO MEMBERS OF THE STAFF WERE PRESCRIBED PROPHYLACTIC ANTIBIOTICS UNTIL THEY HAD THE SPECIALIST LAB RESULTS BACK TO BE SURE OF THE CORRECT IDENTIFICATION. BIOMÉRIEUX CUSTOMER SERVICE INDICATED THAT A CUSTOMER COMMUNICATION WAS PREVIOUSLY ISSUED TO INFORM CUSTOMERS ABOUT POTENTIAL MISIDENTIFICATION AS BRUCELLA SPP WITH VITEK MS KB3.2. THUS FAR, REPORTED INCORRECT ORGANISM IDENTIFICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753396 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE INCONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION AS BRUCELLA SPECIES WHEN USING VITEK MS PRIME INSTRUMENT (REF. 423281, SERIAL NUMBER: (B)(4). CUSTOMER INDICATED THAT DURING THE LAST WEEK, THEY RECEIVED TWO (2) IDENTIFICATIONS AS BRUCELLA WITH 80% AND 99% OF CONFIDENCE BUT NEITHER ISOLATE WAS ACTUALLY BRUCELLA. CUSTOMER INDICATED THAT TWO MEMBERS OF THE STAFF WERE PRESCRIBED PROPHYLACTIC ANTIBIOTICS UNTIL THEY HAD THE SPECIALIST LAB RESULTS BACK TO BE SURE OF THE CORRECT IDENTIFICATION. BIOMÉRIEUX CUSTOMER SERVICE INDICATED THAT A CUSTOMER COMMUNICATION WAS PREVIOUSLY ISSUED TO INFORM CUSTOMERS ABOUT POTENTIAL MISIDENTIFICATION AS BRUCELLA SPP WITH VITEK MS KB3.2. THUS FAR, REPORTED INCORRECT ORGANISM IDENTIFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753383 ↗
• MalfunctionNov 8, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: THE VITEK® MS SYSTEM IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING FOUR (4) MISIDENTIFICATIONS OF MICROCOCCUS SP WHEN USING THE VITEK MS PRIME - REFERENCE (B)(4) (SERIAL NUMBER NOT SPECIFIED). RESULTS: SAMPLE (B)(4). INITIAL TESTING - VITEK MS PRIME = LOW DISCRIMINATION TO MICROCOCCUS LUTEUS / BACILLUS CEREUS GROUP, AND SINGLE CHOICE TO BACILLUS CEREUS GROUP ALTERNATE METHOD - SEQUENCING= MICROCOCCUS LUTEUS SENSU LATO (99.75%) SAMPLE (B)(4). INITIAL TESTING - VITEK MS PRIME = LOW DISCRIMINATION TO ESCHERICHIA COLI / ACINETOBACTER RADIORESISTENS - ALTERNATE METHOD - SEQUENCING = MICROCOCCUS COHNI (100.0%) SAMPLE (B)(4). INITIAL TESTING - VITEK MS PRIME = LOW DISCRIMINATION TO BACTEROIDES OVATUS/XYLANISOLVENS / ENTEROCOCCUS GALLINARUM ALTERNATE METHOD - SEQUENCING = MICROCOCCUS LUTEUS SENSU LATO (99.81%) SAMPLE (B)(4). INITIAL TESTING - VITEK MS PRIME = LOW DISCRIMINATION TO BACILLUS CEREUS GROUP / VIBRIO CHOLERAE ALTERNATE METHOD - SEQUENCING= MICROCOCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753086 ↗
• MalfunctionAug 12, 2022Incorrect Measurement; Incorrect Measurement

  INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN PORTUGAL REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL MISIDENTIFICATION OF STREPTOCOCCUS CONSTELLATUS AS E. COLI WHILE USING VITEK MS PRIME (REF. (B)(4), SERIAL NUMBER (B)(4)). IT WAS REPORTED THAT THE CUSTOMER OBTAINED A POTENTIAL MISIDENTIFICATION WITH A PLEURAL LIQUID SAMPLE WHERE THEY SUSPECTED THAT THE COLONY WAS A STREPTOCOCCUS. THE FIRST TEST RESULT PROVIDED BY VITEK MS PRIME WAS ESCHERICHIA COLI AND THE REPEAT TEST RESULT WAS STREPTOCOCCUS CONSTELLATUS, WHICH WAS THE EXPECTED RESULT. IT WAS REPORTED THAT FOR THE SECOND TEST, THE CULTURE WAS A SUBCULTURE OF THE ORIGINAL PLATE IN COS, PVX AND MCK. SUMMARY: VITEK® MS PRIME FIRST TEST RESULT = E. COLI (LEVEL OF CONFIDENCE NOT REPORTED). VITEK® MS PRIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216013 ↗
• MalfunctionMar 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: VITEK® MS PRIME HAS NOT YET BEEN SOLD IN THE UNITED STATES; HOWEVER, IT IS A SIMILAR PRODUCT TO THE VITEK® MS (REF. 410895). A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS GARDNERELLA VAGINALIS, AND E.COLI AS PSEUDOMONAS AERUGINOSA IN ASSOCIATION WITH VITEK MS PRIME (REF. 423281, SERIAL NUMBER. (B)(4)). THE CUSTOMER ALSO OBTAINED THE EXPECTED IDENTIFICATIONS WITH VITEK MS USING THE SAME SLIDE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13919990 ↗
• MalfunctionMar 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: VITEK® MS PRIME HAS NOT YET BEEN SOLD IN THE UNITED STATES; HOWEVER, IT IS A SIMILAR PRODUCT TO THE VITEK® MS (REF. 410895). A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS GARDNERELLA VAGINALIS, AND E.COLI AS PSEUDOMONAS AERUGINOSA IN ASSOCIATION WITH VITEK MS PRIME (REF. 423281, SERIAL NUMBER. (B)(4). THE CUSTOMER ALSO OBTAINED THE EXPECTED IDENTIFICATIONS WITH VITEK MS USING THE SAME SLIDE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903626 ↗
• MalfunctionMar 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: VITEK® MS PRIME HAS NOT YET BEEN SOLD IN THE UNITED STATES; HOWEVER, IT IS A SIMILAR PRODUCT TO THE VITEK® MS (REF. 410895). A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS GARDNERELLA VAGINALIS, AND E.COLI AS PSEUDOMONAS AERUGINOSA IN ASSOCIATION WITH VITEK MS PRIME (REF. 423281, SERIAL NUMBER. (B)(4). THE CUSTOMER ALSO OBTAINED THE EXPECTED IDENTIFICATIONS WITH VITEK MS USING THE SAME SLIDE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903419 ↗