VITEK® 2 ANCRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03573026529727), received between Feb 3, 2016 and May 17, 2018 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM ITALY REPORTED A MISIDENTIFICATION OF A CLOSTRIDIUM SPOROGENES (ATCC® 11437) INTERNAL QUALITY CONTROL STRAIN AS LOW DISCRIMINATION ORGANISM IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT. THE CUSTOMER STATED THAT THE ANC CARD GAVE A LOW DISCRIMINATION ORGANISM RESULT FIVE TIMES. THE CUSTOMER HAD PERFORMED ONE QC WHICH WAS COMPLIANT. THE CUSTOMER USED CBA MEDIUM FOR 24 HOURS THEN SUBCULTURED AND INOCULATED THE STRAIN ON ANC CARDS. THE GRAM STAIN WAS GRAM POSITIVE BACILLI. THE CUSTOMER HAD CLEANED THE OPTICS AND THE VITEK SYSTEM DID NOT GIVE ANY ERRORS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QUALITY CONTROL STRAIN. THE INSTRUCTIONS FOR USE (REF.043907-02), INDICATES THE ATCC 11437 C. SPOROGENES STRAIN IS NOT RECOMMENDED FOR ANC CARDS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7522627 ↗
• MalfunctionMay 16, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING THE CLOSTRIDIUM SPOROGENES ATCC® 11437¿ STRAIN WITH VITEK® 2 ANC ID TEST KIT (REFERENCE 21347). THE CUSTOMER REPORTED TESTING THE ISOLATE THREE (3) TIMES WITH THE FOLLOWING METHODS AND RESULTS: 1- USING TSA MEDIA AND AFTER 24 HOURS OF INCUBATION IN ANAEROBIC ATMOSPHERE , THE CUSTOMER OBTAINED AN IDENTIFICATION OF SLASHLINE (MIXED) CLOSTRIDIUM GROUP. 2- USING CBA MEDIA AND AFTER 24 HOURS OF INCUBATION, STILL IN IN ANAEROBIC ATMOSPHERE, THE CUSTOMER OBTAINED THE SAME RESULT AS SLASHLINE CLOSTRIDIUM GROUP. 3- USING CBA MEDIA (THAT IS A RECOMMENDED MEDIA FOR VITEK® 2) AND AFTER 48 HOURS OF INCUBATION, THE CUSTOMER OBTAINED A LOW DISCRIMINATION FOR CLOSTRIDIUM GROUP. THE CUSTOMER REPORTED USING AN ISOLATED ORGANISM FROM THE MEDIA WHERE HE OBSERVED SINGLE COLONIES. THIS SAME ATCC STRAIN HAS BEEN IDENTIFIED WITH THE MALDI SYSTEM AS C. SPOROGENES SPECIES. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. TO BE NOTED, AS SPECIFIED IN THE INSTRUCTIONS FOR USE (REF.043907-02), THE IMPACTED ATCC 11437 C. SPOROGENES STRAIN IS

  Patient problems: No Patient Involvement

  MAUDE report 7519878 ↗
• MalfunctionMay 9, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM MALAYSIA REPORTED A MISIDENTIFICATION OF CORYNEBACTERIUM DIPHTHERIAE FROM A THROAT SPECIMEN IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT (LOT 2440285403). A CUSTOMER FIRST IDENTIFIED C. DIPHTHERIAE WITH A HIGH CONFIDENCE LEVEL USING API® CORYNE. THE ISOLATE WAS THEN SENT TO A SECOND CUSTOMER FOR CONFIRMATION USING VITEK® 2. THE ISOLATE WAS TESTED MULTIPLE TIMES WITH THE ANC CARD, AND VARIOUS IDENTIFICATIONS WERE OBTAINED: C. ULCERANS , LOW DISCRIMINATION TO C. AMYCOLATUM AND ATOPOBIUM VAGINAE, UNIDENTIFIED, AND LOW DISCRIMINATION TO C. AMYCOLATUM AND C. DIPHTHERIAE. THE FIRST CUSTOMER THEN RETESTED THE ISOLATE WITH THE BD BBL¿ CRYSTAL¿ IDENTIFICATION SYSTEM WHICH RESULTED IN C. DIPHTHERIA (99%). THE CUSTOMER STATED THE RESULT OF C. DIPHTHERIA WAS REPORTED TO THE CLINICIAN. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO PATIENT RESULTS OR TREATMENT. THE LOCAL FIELD APPLICATION SPECIALIST (FAS) TESTED THE ISOLATE AT THE CUSTOMER SITE AND RECEIVED A LOW DISCRIMINATION TO C. AMYCOLATUM AND A. VAGINAE WITH THE VITEK 2. THE FAS THEN TESTED THE ISOLATE AT ANOTHER CUSTOMER SITE AND THEIR OWN LAB, WITH VITEK 2 AND VITEK MS INSTRUMENTS. THE VITEK 2 RESULTS WERE LOW DISCRI

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 7500670 ↗
• MalfunctionMay 9, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER FROM MALAYSIA REPORTED A MISIDENTIFICATION OF CORYNEBACTERIUM DIPHTHERIAE FROM A THROAT SPECIMEN IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT (LOT 2440422103). A CUSTOMER FIRST IDENTIFIED C. DIPHTHERIAE WITH A HIGH CONFIDENCE LEVEL USING API® CORYNE. THE ISOLATE WAS THEN SENT TO A SECOND CUSTOMER FOR CONFIRMATION USING VITEK® 2. THE ISOLATE WAS TESTED MULTIPLE TIMES WITH THE ANC CARD, AND VARIOUS IDENTIFICATIONS WERE OBTAINED: C. ULCERANS , LOW DISCRIMINATION TO C. AMYCOLATUM AND ATOPOBIUM VAGINAE, UNIDENTIFIED, AND LOW DISCRIMINATION TO C. AMYCOLATUM AND C. DIPHTHERIAE. THE FIRST CUSTOMER THEN RETESTED THE ISOLATE WITH THE BD BBL¿ CRYSTAL¿ IDENTIFICATION SYSTEM WHICH RESULTED IN C. DIPHTHERIA (99%). THE CUSTOMER STATED THE RESULT OF C. DIPHTHERIA WAS REPORTED TO THE CLINICIAN. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO PATIENT RESULTS OR TREATMENT. THE LOCAL FIELD APPLICATION SPECIALIST (FAS) TESTED THE ISOLATE AT THE CUSTOMER SITE AND RECEIVED A LOW DISCRIMINATION TO C. AMYCOLATUM AND A. VAGINAE WITH THE VITEK 2. THE FAS THEN TESTED THE ISOLATE AT ANOTHER CUSTOMER SITE AND THEIR OWN LAB, WITH VITEK 2 AND VITEK MS INSTRUMENTS. THE VITEK 2 RESULTS WERE LOW DISCRI

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 7500669 ↗
• MalfunctionApr 25, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF CORYNEBACTERIUM MACGINLEYI FROM A PATIENT ISOLATE (EYE SORE), AS PROPONOBACTERIUM ACNES IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT 20CARDS (LOT 2440440103). THE CUSTOMER STATED THAT WHILE TESTING A GRAM POSITIVE BACILLUS STRAIN FROM THE PATIENT ISOLATE ON COS AND CAN MEDIA, A GROWTH WAS OBSERVED THAT SUGGESTED A POTENTIAL CORYNEBACTERIUM SPECIES. THE CUSTOMER TESTED THE STRAIN ON THE ANC CARD, AND AN IDENTIFICATION OF PROPONOBACTERIUM ACNES (95%) WAS OBTAINED. THE CUSTOMER SENT THE STRAIN TO THE NATIONAL REFERENCE CENTER FOR TESTING AND THE RESULT WAS CORYNEBACTERIUM MACGINLEYI BY MASS SPECTROMETRY. NO INCORRECT RESULT WAS REPORTED TO THE CLINICIAN, BUT THERE WAS A 48 HOUR DELAY IN REPORTING RESULTS DUE TO COMPLEMENTARY TESTING. CORYNEBACTERIUM MACGINLEYI SPECIES IS NOT A CLAIMED SPECIES FOR VITEK 2 ANC CARDS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461442 ↗
• MalfunctionMar 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION FOR BACTEROIDES OVATUS ATCC® BAA-1296¿ IN ASSOCIATION WITH THE VITEK® 2 ANC ID TEST KIT. THE ORGANISM WAS REPORTED AS BACTEROIDES STERCORIS, BACTEROIDES EGGERTHII, LOW DISCRIM PREVOTELLA ORALIS/BACTEROIDES EGGERTHII, AND PREVOTELLA ORALIS. 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 WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE ATCC® STRAIN. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7373423 ↗
• MalfunctionFeb 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF EGGERTHELLA LENTA ((B)(6)) AS ACTINOMYCES ODONTOLYTICUS IN ASSOCIATION WITH THE VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) ID TEST KIT. THE CUSTOMER REPORTED THE RESULT TO (B)(6) AS ACTINOMYCES SPECIES. UPON RECEIVING THE (B)(6) REPORT INDICATING EGGERTHELLA LENTA, REPEAT TESTING WAS PERFORMED AND OBTAINED EGGERTHIA CATENAFORMIS. 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 WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE (B)(6) STRAIN. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX TO BE AVAILABLE FOR INTERNAL INVESTIGATION; HOWEVER, THE CUSTOMER STATED IT WAS LIKELY NO LONGER VIABLE. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7292527 ↗
• MalfunctionJan 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 ANC TEST KIT (REFERENCE 21347). THE CUSTOMER REPORTED THAT THEY MISSED CAP D-B SAMPLE D10. CUSTOMER REPORTED PEPTOSTREPTOCOCCUS ANAEROBIUS BASED ON A COCCOBACILLI NOMENCLATURE, BUT SHOULD HAVE BEEN PROPIONIBACTERIUM ACNES (OLD NOMENCLATURE) OR CUTIBACTERIUM ACNES (NEW NOMENCLATURE) USING A BACILLI MORPHOLOGY. THE CUSTOMER REPEATED ON THEIR SECOND SWAB WITH BACILLI MORPHOLOGY AND GOT LOW DISCRIMINATION WITH SEVERAL CLOSTRIDIUM SPECIES. BACILLI MORPHOLOGY DID NOT SHOW UNTIL DAY SEVEN (7) OF INCUBATION. CUSTOMER TESTED AT 48 HOURS AFTER SUBCULTURING TWO TIMES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185432 ↗
• MalfunctionJan 10, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF THE MISIDENTIFICATION OF A PROBIOQUAL EXTERNAL QUALITY CONTROL SAMPLE, 17CA2A, WHEN TESTING WITH VITEK® 2 ANC TEST KIT (REF 21347). THE EXPECTED IDENTIFICATION IS CORYNEBACTERIUM UREALYTICUM. THE CUSTOMER STATED THEY TESTED TWICE WITH VITEK 2. THEY INITIALLY OBTAINED A RESULT OF "UNIDENTIFIED ORGANISM," AND THE SECOND RESULT WAS 99% CLOSTRIDIUM GROUP. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT QUALITY RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7179165 ↗
• MalfunctionNov 22, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF 21347). THE CUSTOMER REPORTED THAT THREE PATIENT STRAINS WERE TESTED WITH VITEK® 2, WHICH PROVIDED IDENTIFICATIONS OF FUSOBACTERIUM NUCLEATUM. VITEK® MS WAS USED TO TEST THE ISOLATES, AND IT PROVIDED EITHER A "NO ID" RESULT OR CAMPYLOBACTER JEJUNI RESULT. THE STATE LAB IDENTIFIED THE STRAINS AS CAMPYLOBACTER CONCISUS USING THE BRUKER METHOD. FUSOBACTERIUM NUCLEATUM WAS INCORRECTLY REPORTED TO THE PHYSICIAN FOR ONE OF THE PATIENTS. THERE IS NO INFORMATION ON REPORTED RESULTS FOR THE OTHER TWO PATIENTS. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052832 ↗
• MalfunctionNov 22, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF 21347). THE CUSTOMER REPORTED THAT THREE PATIENT STRAINS WERE TESTED WITH VITEK® 2, WHICH PROVIDED IDENTIFICATIONS OF FUSOBACTERIUM NUCLEATUM. VITEK® MS WAS USED TO TEST THE ISOLATES, AND IT PROVIDED EITHER A "NO ID" RESULT OR CAMPYLOBACTER JEJUNI RESULT. THE STATE LAB IDENTIFIED THE STRAINS AS CAMPYLOBACTER CONCISUS USING THE BRUKER METHOD. FUSOBACTERIUM NUCLEATUM WAS INCORRECTLY REPORTED TO THE PHYSICIAN FOR ONE OF THE PATIENTS. THERE IS NO INFORMATION ON REPORTED RESULTS FOR THE OTHER TWO PATIENTS. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052776 ↗
• MalfunctionNov 21, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF (B)(4)). THE CUSTOMER REPORTED THAT THREE PATIENT STRAINS WERE TESTED WITH VITEK® 2, WHICH PROVIDED IDENTIFICATIONS OF FUSOBACTERIUM NUCLEATUM. VITEK® MS WAS USED TO TEST THE ISOLATES, AND IT PROVIDED EITHER A "NO ID" RESULT OR CAMPYLOBACTER JEJUNI RESULT. THE STATE LAB IDENTIFIED THE STRAINS AS CAMPYLOBACTER CONCISUS USING THE BRUKER METHOD. FUSOBACTERIUM NUCLEATUM WAS INCORRECTLY REPORTED TO THE PHYSICIAN FOR ONE OF THE PATIENTS. THERE IS NO INFORMATION ON REPORTED RESULTS FOR THE OTHER TWO PATIENTS. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050723 ↗
• MalfunctionNov 16, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR BACTEROIDES FRAGILIS (B)(4) STRAIN IN ASSOCIATION WITH VITEK® 2 ANC TEST KIT (REF 21347). THE STRAIN WAS TESTED THREE TIMES WITH VITEK® 2, WHICH PROVIDED THE FOLLOWING IDENTIFICATIONS: FIRST TEST: BACTEROIDES STERCORIS 95%. SECOND TEST: PREVOTELLA BIVIA 95%. THIRD TEST: BACTEROIDES STERCORIS 95%. 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 WAS NO PATIENT ASSOCIATED WITH THIS QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7038388 ↗
• MalfunctionJun 1, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAP SURVEY STRAIN CLOSTRIDIUM SEPTICUM AS CLOSTRIDIUM CLOSTRIDIFORME IN ASSOCIATION WITH THE VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT. UPON THE ADVICE OF BIOMÉRIEUX SUPPORT PERSONNEL, THE CUSTOMER REPEATED TESTING USING A SECOND SWAB; THE EXPECTED CAP ID OF CLOSTRIDIUM SEPTICUM WAS OBTAINED. 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 WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CAP SURVEY STRAIN. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6605333 ↗
• MalfunctionMay 30, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 ANC TEST KIT. THE CUSTOMER REPORTED THAT THEY HAD A CAP SURVEY ORGANISM THAT WAS IDENTIFIED BY VITEK® 2 AS CLOSTRIDIUM CLOSTRIDIIFORME AND THE EXPECTED RESULT WAS CLOST SEPTICUM. AFTER RECEIVING THE CAP RESULTS, A SECOND SWAB WAS TESTED AND THE EXPECTED RESULT OF CLOST SEPTICUM WAS OBTAINED. NO PATIENT IS INVOLVED IN THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 6597321 ↗
• MalfunctionApr 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 ANC TEST KIT (REFERENCE 21347). THE CUSTOMER REPORTED THE VITEK® 2 ANC CARD RESULTS AS ANAEROCOCCUS PREVOTII BUT AN ALTERNATIVE TESTING METHOD VMS RESULTS REPORTED OLIGELLA URETHRALIS. THE CUSTOMER REPORTED THAT ELEVEN (11) TESTS WERE RUN ON THE VITEK® 2, TEN (10) RESULTED IN NO IDENTIFICATION AND ONE (1) RESULT WAS TOO NOISY TO GIVE A RESULT. THE VITEK® INSTRUMENT WAS FINE-TUNED AND THE CUSTOMER REPORTED THE SYSTEM WAS NOT WORKING AS EXPECTED. THE IDENTIFICATION RESULTS WERE NORMAL AND ANAEROCOCCUS SPECIES NOT PRESENT IN THE VITEK® 2. THE CUSTOMER REPORTED USING ANOTHER METHOD. THE REFERENCE METHOD USED WAS SEQUENCING, GENUS USED THE SAME METHOD AS THE VITEK® 2 BUT NOT THE SAME SPECIES NAME. THE ANALYSIS OF NEW DATA FROM THE CUSTOMER (DATA FROM NEW TESTS) WITH NEXT VITEK® 2, (WHICH CONTAINS 3 SPECIES OF ANAEROCOCCUS : ANAEROCOCCUS PREVOTII, ANAEROCOCCUS TETRADIUS, ANAEROCOCCUS VAGINALIS), THE CUSTOMER REPORTED THAT THE RESULTS AGAIN ANAEROCOCCUS TETRADIUS FOR TWO (2) OF THE ELEVEN (11) TESTS WITH KB V3.1 INDUSTRY AND KB V3.2 (NEXT KB) AND 1 OF THE 11 TESTS WITH KB V3.0 CLINIC. CULTURE SUBMITTAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529211 ↗
• MalfunctionFeb 3, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT. PROPIONIBACTERIUM SPECIES WAS MISIDENTIFIED AS ATOPODIUM VAGINAE. UPON OBTAINING ATOPODIUM VAGINAE RESULT FOR A MALE PATIENT, AN ALTERNATE METHOD OF TESTING (CRYSTAL) WAS EMPLOYED. THE RESULT OF PROPIONIBACTERIUM AGNES (OR GRANUSLOSUM) WAS OBTAINED. 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. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5407895 ↗