VITEK® MS 410895Recalls & reported problems

Summary

The FDA's MAUDE database contains 615 adverse event reports that list this exact device (DI 03573026359119), received between Jan 26, 2017 and May 6, 2026 — classified as 6 injuries, 609 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (467 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 615 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Incorrect Measurement

  IT WAS REPORTED THAT PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 AND GOT TREATED WITH PUMP.

  Patient problems: Insufficient Information

  MAUDE report 25092481 ↗
• MalfunctionApr 16, 2025Incorrect 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 CANADA NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF AN UNKNOWN ISOLATE AS BRUCELLA SP. ASSOCIATED WITH VITEK MS INSTRUMENT - REF. (B)(4), LOT UNKNOWN. THE CUSTOMER NOTED THAT THE ISOLATE HAD BEEN IDENTIFIED AS BRUCELLA SP VIA VITEK MS BUT THE GRAM STAIN RESULTS WERE TINY GRAM NEGATIVE RODS. THE PHYSICIAN DOES NOT BELIEVE THE RESULT OF BRUCELLA SP. 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 ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847853 ↗
• MalfunctionDec 27, 2024Incorrect 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 GERMANY NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED A MISIDENTIFICATION OF AN UNSPECIFIED ORGANISM AS BRUCELLA IN ASSOCIATION WITH THEIR VITEK MS (REF (B)(4) SERIAL (B)(6)). THE CUSTOMER REPORTED THAT THEY OBTAINED AN IDENTIFICATION OF BRUCELLA WITH THE VITEK MS WHILE AN EXTERNAL LABORATORY CONFIRMED, BY DNA ANALYSIS, THAT THE ORGANISM WAS NOT BRUCELLA. THE PRECISE IDENTIFICATION OF THE ORGANISM HAS NOT BEEN PROVIDED. THE CUSTOMER CONFIRMED THAT THE MISIDENTIFICATION DID NOT LEAD TO OR CONTRIBUTE TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027314 ↗
• MalfunctionAug 28, 2024Incorrect 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 CANADA NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS BRUCELLA SPP ASSOCIATED WITH VITEK MS PRIME - REF.(B)(4). THE CUSTOMER PERFORMED TESTING AT 24 HOURS OF INCUBATION WITH RESULTS OF BRUCELLA SPP. THE CUSTOMER THEN CONTINUED INCUBATION AND PERFORMED TESTING OF THE SAME ISOLATE / AGAR PLATE AT 48 HOURS WITH RESULTS OF STAPHYLOCOCCUS AUREUS. 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. 14-AUG-2024 NOTE: CANADA LOCAL CUSTOMER SERVICE NOTIFIED THAT THE INTIAL PRODUCT REFERENCE VITEK MS PRIME 423281 DOCUMENTED IN THE COMPLAINT RECORD WAS INCORRECT. THE ACTUAL PRODUCT REFERENCE IS VITEK MS INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083510 ↗
• MalfunctionAug 22, 2024Incorrect Measurement; Incorrect Measurement

  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 NEW ZEALAND NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF MORAXELLA LINCOLNI AS BRUCELLA SP. ASSOCIATED WITH VITEK MS INSTRUMENT - REF. 410895, LOT UNKNOWN. THE CUSTOMER NOTED THAT THE ISOLATE HAD BEEN IDENTIFIED AS BRUCELLA SP. ON TWO VITEK MS INSTRUMENTS IN SEPARATE LABS. THE ISOLATE WAS THEN SENT OUT FOR SEQUENCING CONFIRMING THE EXPECTED IDENTIFICATION OF MORAXELLA LINCOLNI. 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 ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026296 ↗
• MalfunctionMar 4, 2024Incorrect 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 THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS BRUCELLA SPP. IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6)). THE CUSTOMER INDICATED THAT ONE PATIENT SAMPLE WAS IDENTIFIED AS BRUCELLA SPP. UPON INITIAL TESTING. REPEAT TESTING RESULTED IN AN IDENTIFICATION OF STAPHYLOCOCCUS AUREUS. 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. NOTE: (B)(6) IS UNDER ASSESSMENT QUALIFICATION. THE CONTENT OF THIS ASSESSMENT HAS BEEN COMPLETED WITH THE ASSISTANCE OF (B)(6). REVIEW AND SUBMISSION PREFORMED BY (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832749 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6)), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6)). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): **VITEK MS SN (B)(6) RESULTS : -LAB ID (B)(4) 5 NO IDENTIFICATION 2 SINGLE CHOICE TO BRUCELLA SPP 1 SINGLE CHOICE TO STAPHYLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490860 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6)), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6)). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): **VITEK MS SN (B)(6) RESULTS : -LAB ID (B)(4) 5 NO IDENTIFICATION 2 SINGLE CHOICE TO BRUCELLA SPP 1 SINGLE CHOICE TO STAPHYLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490855 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): VITEK MS SN 52681 RESULTS : LAB ID (B)(4). 3 SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS. 1 SINGLE CHOICE TO BRUCELLA SPP. 1 SINGLE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490850 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6)), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6)). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): **VITEK MS SN (B)(6) RESULTS : -LAB ID (B)(4) 3 SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS. 1 SINGLE CHOICE TO BRUCELLA SPP. 1 SIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490847 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6)), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6)). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): **VITEK MS SN (B)(6) RESULTS : -LAB ID (B)(4) 3 SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS 1 SINGLE CHOICE TO BRUCELLA SPP 1 SINGL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490846 ↗
• MalfunctionJan 11, 2024Incorrect 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 RUSSIA REPORTED TO BIOMÉRIEUX POTENTIAL MULTIPLE MISIDENTIFICATIONS FOR THREE PATIENT SAMPLES IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER (B)(6) ), WITH KNOWLEDGE BASE VERSION 3.2. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VITEK MS INSTRUMENT SERIAL NUMBER (B)(6) ). CUSTOMER OBTAINED DISCREPANT RESULTS BETWEEN VITEK MS AND VITEK 2 WITH POTENTIAL WRONG IDENTIFICATIONS PROVIDED BY VITEK MS FOR THREE SAMPLES COMING FROM THREE PATIENTS, TESTED ON TWO INSTRUMENTS; THE RESULTS WERE AS FOLLOWS FOR VITEK MS INSTRUMENT, SERIAL NUMBER (B)(6): **VITEK MS SN (B)(6) RESULTS : -LAB ID 30782526. 5 NO IDENTIFICATION. 2 SINGLE CHOICE TO BRUCELLA SPP. 1 SINGLE CHOICE TO ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490829 ↗
• MalfunctionNov 30, 2023Incorrect 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 THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF TWO (2) STAPHYLOCOCCUS AUREUS PATIENT ISOLATES AS BRUCELLA SP. ASSOCIATED WITH VITEK MS INSTRUMENT - REF. (B)(4), SERIAL NUMBER (B)(6). THE CUSTOMER INDICATED THAT TWO PATIENT SAMPLES WERE IDENTIFIED AS BRUCELLA SP. UPON INITIAL TESTING. REPEAT TESTING FOR ONE OF THE ISOLATES RESULTED IN AN IDENTIFICATION OF STAPHYLOCOCCUS AUREUS. THE CUSTOMER PERFORMED ALTERNATE METHOD TESTING BY CONFIRMING PURITY AND A POSITIVE STAPHAUREX TEST. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242244 ↗
• MalfunctionNov 30, 2023Incorrect 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 THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF TWO (2) STAPHYLOCOCCUS AUREUS PATIENT ISOLATES AS BRUCELLA SP. ASSOCIATED WITH VITEK MS INSTRUMENT - REF. (B)(4), SERIAL NUMBER (B)(6). THE CUSTOMER INDICATED THAT TWO PATIENT SAMPLES WERE IDENTIFIED AS (B)(6). UPON INITIAL TESTING. REPEAT TESTING FOR ONE OF THE ISOLATES RESULTED IN AN IDENTIFICATION OF STAPHYLOCOCCUS AUREUS. THE CUSTOMER PERFORMED ALTERNATE METHOD TESTING BY CONFIRMING PURITY AND A POSITIVE STAPHAUREX TEST. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238981 ↗
• MalfunctionNov 29, 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 HONG KONG NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF A BLOOD CULTURE SPECIMEN AS BRUCELLA SPP WHEN USING THE VITEK MS - REFERENCE (B)(4) ( SERIAL NUMBER : (B)(6) . INDEED, VITEK MS RESULT BRUCELLA SPP. DOES NOT MATCH GRAM-STAIN RESULT. CUSTOMER OBTAINED A POSITIVE BLOOD CULTURE SPECIMEN, AND SUBCULTURED IT ON HORSE BLOOD AGAR, INCUBATED AT 35 DEGREE CELSIUS WITH 5% CO2 FOR 48 HOURS. THE COLONY WAS PURE. THE GROWTH WAS POOR, AS DESCRIBED BY CUSTOMER. SUMMARY VITEK MS RESULTS NOT ENOUGH PEAK, NOT ENOUGH PEAK, BRUCELLA SPP. ¿ 98.8%, BRUCELLA SPP. ¿ 99.9%, NOT ENOUGH PEAK, NO IDENTIFICATION ADDITIONAL TESTING GRAM STAIN: GRAM POSITIVE, ROD, BEADED, SANGER SEQUENCING ¿ MYCOBACTERIUM SPECIES. THE CUSTOMER INDICATES THE REPORTING RESULT HAS BEEN DELAYED BY 4 HOURS. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225866 ↗
• MalfunctionOct 31, 2023Incorrect 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 PORTUGAL REPORTED TO BIOMÉRIEUX A POTENTIAL MISIDENTIFICATION AS BRUCELLA SPP IN ASSOCIATION WITH THE PRODUCT VITEK MS INSTRUMENT REF (B)(4), SERIAL NUMBER (B)(6) WITH A SAMPLE. CUSTOMER HAS OBTAINED A DOUBTFUL BRUCELLA SPP. IDENTIFICATION FOR A ROD-SHAPED GRAM POSITIVE MICROORGANISM. AS IT WAS SEEN IN THE REPORTS, THE FIRST ATTEMPT GAVE BRUCELLA SPP/ BACILLUS CEREUS GROUP LOW DISCRIMINATION. AFTER THAT, THERE WAS A BRUCELLA SPP 99,9% RESULT. FINALLY, FOR THE THIRD ATTEMPT, THEY OBTAINED NO ID RESULT DUE TO BAD SPECTRUM. INCUBATION WAS 48H, 30-35ºC IN TSA PLATE. AT THE TIME OF THE GLOBAL ASSESSMENT, THE EXPECTED RESULT IS NOT CONFIRMED, THE CUSTOMER WAS STILL CONSIDERING IF THEY WANT TO SEND THIS SAMPLE FOR EXTERNAL ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039157 ↗
• MalfunctionAug 18, 2023Incorrect 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 THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF AN UNKNOWN ISOLATE AS BRUCELLA SPP ASSOCIATED WITH VITEK MS INSTRUMENT - REF. 410895, LOT UNKNOWN. THE CUSTOMER INDICATED THAT UPON IDENTIFICATION OF BRUCELLA THE ISOLATE WAS SENT TO ANOTHER LAB FOR ADDITIONAL TESTING. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PERSON'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572201 ↗
• MalfunctionJul 31, 2023Incorrect 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 HONG KONG NOTIFIED BIOMERIEUX OF OBTAINING A MISIDENTIFICATION OF A STAPHYLOCOCCUS AUREUS AS BRUCELLA SPP WHEN TESTING A BLOOD CULTURE SPECIMEN WITH THE VITEK MS SERIAL# (B)(6). INDEED, UPON IDENTIFICATION BY VITEK MS, BRUCELLA SPP. WAS REPORTED WITH 99.9%. CUSTOMER REPEATED TESTING BY RE-SPOTTING, AND OBTAINED A RESULT OF S. AUREUS WITH 99.9%. GRAM STAIN SUGGESTED THAT S. AUREUS SHOULD BE THE CORRECT RESULT AS GRAM STAIN REVEALED THAT THE SPECIMEN IS GRAM + COCCUS. SUMMARY: BLOOD CULTURE SPECIMEN. INITIAL TESTING - VITEK MS. BRUCELLA SP. REPEAT TESTING - VITEK MS. STAPHYLOCOCCUS AUREUS. 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 17430068 ↗
• MalfunctionJul 28, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATIONTIME 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. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS AN INCORRECT IDENTIFICATION TEST RESULT WHEN TESTING A MICROOGANISM ISOLATED FROM ONE PATIENT'S SAMPLE WITH THEIR VITEK® MS (REF 410895). THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A COLONY ISOLATED FROM A PATIENT'S SAMPLE USING THEIR VITEK MS SYSTEM AND THAT THE STRAIN WAS IDENTIFIED AS BRUCELLA SPP. WITH 83.6 CONFIDENCE VALUE. THE CUSTOMER SAID THAT ON THE SAME DAY THEY HAD RERUN OF THE SAMPLE AND THAT THE STRAIN WAS IDENTIFIED AS ESCHERICHIA COLI WITH 99.9 CONFIDENCE VALUE. THE CUSTOMER SAID THAT BASED ON CULTURE AND ISOLATION TESTING THE MICROOGANISM IS ESCHERICHIA COLI. NO FURTHER DETAIL WERE PROVIDED. THERE IS NO INDICATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413884 ↗
• MalfunctionJul 20, 2023Incorrect 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. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED AN INCORRECT IDENTIFICATION TEST RESULT WHEN TESTING A MICROORGANISM ISOLATED FROM A PATIENT SAMPLE (SPUTUM SPECIMEN) FOR IDENTIFICATION TEST USING BIOMÉRIEUX MASS SPECTROMETRY TECHNIQUE. THE CUSTOMER SAID THAT THEY HAD TESTED A COLONY ISOLATED FROM A PATIENT SAMPLE USING THEIR VITEK® MS INSTRUMENT (REF. 410895, SERIAL# NUMBER 51427), KNOWLEDGE BASE (KB) VERSION 3.0 AND THAT THE MICROORGANISM WAS IDENTIFIED AS BRUCELLA SP. 98.6% WITH MEDIUM CONFIDENCE LEVEL. CUSTOMER STATED THAT THE ORGANISM DID NOT MATCH BRUCELLA MORPHOLOGICALLY AND IT WAS A GRAM NEGATIVE ROD FROM A SPUTUM SPECIMEN. FOLLOW-UP TESTING WAS CATALASE POSITIVE AND OXIDASE POSITIVE. THE CUSTOMER STATED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363075 ↗
• MalfunctionMay 31, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATIONTIME 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. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS INCORRECT IDENTIFICATION TEST RESULTS WHEN TESTING A MICROOGANISM ISOLATED FROM THREE DIFFERENT PATIENTS' SAMPLES' WITH THEIR VITEK® MS (REF 410895). THE CUSTOMER REPORTED THAT THEY HAD TESTED A COLONY ISOLATED FROM THROAT CULTURE OF PATIENT'S SAMPLE 1 USING THEIR VITEK MS SYSTEM AND THAT THE STRAIN WAS IDENTIFIED AS BRUCELLA SP. WITH A LOW SCORE. THE CUSTOMER SAID THAT BASED ON CULTURE AND ISOLATION TESTING THEY SUSPECT THE MICROOGANISM TO BE GROUP A STREPTOCOCCUS. THE CUSTOMER REPORTED THAT THEY HAD OBSERVED THE SAME ISSUE WHEN TESTING A COLONY ISOLATED FROM A URINE SAMPE OF PATIENT'S SAMPLE 2 AND A COLONY ISOLATED FROM THROAT SAMPLE OF PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030838 ↗
• MalfunctionMay 31, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATIONTIME 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. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS INCORRECT IDENTIFICATION TEST RESULTS WHEN TESTING A MICROOGANISM ISOLATED FROM THREE DIFFERENT PATIENTS' SAMPLES' WITH THEIR VITEK® MS (REF 410895). THE CUSTOMER REPORTED THAT THEY HAD TESTED A COLONY ISOLATED FROM THROAT CULTURE OF PATIENT'S SAMPLE 1 USING THEIR VITEK MS SYSTEM AND THAT THE STRAIN WAS IDENTIFIED AS BRUCELLA SP. WITH A LOW SCORE. THE CUSTOMER SAID THAT BASED ON CULTURE AND ISOLATION TESTING THEY SUSPECT THE MICROOGANISM TO BE GROUP A STREPTOCOCCUS. THE CUSTOMER REPORTED THAT THEY HAD OBSERVED THE SAME ISSUE WHEN TESTING A COLONY ISOLATED FROM A URINE SAMPLE OF PATIENT'S SAMPLE 2 AND A COLONY ISOLATED FROM THROAT SAMPLE OF PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030828 ↗
• MalfunctionMay 31, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATIONTIME 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. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS INCORRECT IDENTIFICATION TEST RESULTS WHEN TESTING A MICROOGANISM ISOLATED FROM THREE DIFFERENT PATIENTS' SAMPLES' WITH THEIR VITEK® MS (REF 410895). THE CUSTOMER REPORTED THAT THEY HAD TESTED A COLONY ISOLATED FROM THROAT CULTURE OF PATIENT'S SAMPLE 1 USING THEIR VITEK MS SYSTEM AND THAT THE STRAIN WAS IDENTIFIED AS BRUCELLA SP. WITH A LOW SCORE. THE CUSTOMER SAID THAT BASED ON CULTURE AND ISOLATION TESTING THEY SUSPECT THE MICROORGANISM TO BE GROUP A STREPTOCOCCUS. THE CUSTOMER REPORTED THAT THEY HAD OBSERVED THE SAME ISSUE WHEN TESTING A COLONY ISOLATED FROM A URINE SAMPLE OF PATIENT'S SAMPLE 2 AND A COLONY ISOLATED FROM THROAT SAMPLE OF PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030820 ↗
• MalfunctionMay 5, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT 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. COMPLAINT DESCRIPTION: A CUSTOMER IN CHINESE TAIPEI COMPLAINED AFTER HAVING OBTAINED WHAT THEY DESCRIBED AS INCORRECT IDENTIFICATION TEST RESULTS WHEN TESTING THREE DIFFERENT PATIENTS' SAMPLES WITH THEIR VITEK® (B)(4). THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A COLONY ISOLATED FROM A ABSCESS SAMPLE PATIENT A -ID (B)(6), USING THEIR VITEK MS SYSTEM AND THAT THEY HAD OBTAINED AN EXCELLENT IDENTIFICATION OF STREPTOCOCCUS AGALACTIAE. THE CUSTOMER SAID THAT ON (B)(6) 2023, THEY HAD TESTED A COLONY ISOLATED FROM A URINE CULTURE PATIENT B - ID (B)(6), USING THE SAME VITEK MS SYSTEM VITEK MS AND THAT THEY HAD OBTAINED AN EXCELLENT IDENTIFICATION OF SALMONELLA ENTERICA SPP ENTERICA. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875852 ↗
• MalfunctionApr 17, 2023Incorrect 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. DESCRIPTION OF ISSUE: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A SUSPECTED ORGANISM MISIDENTIFICATION AS BRUCELLA SPECIES IN ASSOCIATION WITH THE VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER (B)(6). CUSTOMER STATES THEY INSPECTED THE PLATE IN AN ATTEMPT TO FIND A COLONY THAT COULD POSSIBLY HAVE IDENTIFIED AS BRUCELLA, AND THEY COULD NOT LOCATE ONE. THE CUSTOMER ALSO INDICATED THEY COULD NOT REPRODUCE THE BRUCELLA RESULT. SUMMARY: DATE OF TESTING: (B)(6) 2023 WOUND CULTURE. EXPECTED RESULT: UNKNOWN. HOWEVER, ALL ISOLATES ON MEDIA PLATE GRAM-STAINED AS GRAM-POSITIVE COCCI OR GRAM-POSITIVE BACILLUS, RESEMBLING DIPTHEROIDS. RESULT OBTAINED : BRUCELLA SPP. 99.9 % MEDIA AND INCUBATION : BAP MEDIA, INCUBATION PERIOD : APPROXIMATELY 30 HOURS THERE IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751817 ↗