VITEK® 2 GNRecalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 03573026529987), received between Apr 28, 2017 and Oct 2, 2019 — classified as 8 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (90 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0787-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT OF ESCHERICHIA COLI (E. COLI) AS SALMONELLA ENTERICA SSP DIARIZONAE WHEN TESTING A PATIENT URINE SAMPLE WITH THE VITEK®2 GN ID TEST KIT (REFERENCE 21341, LOT 2410809103). REPEAT TESTING USING THE VITEK 2 GN ID TEST KIT WAS PERFORMED TWO ADDITIONAL TIMES; BOTH REPEAT TESTS IDENTIFIED THE ISOLATE AS SALMONELLA ENTERICA SSP DIARIZONAE. THE CUSTOMER ALSO SENT THE ISOLATE OUT FOR MALDI TOF TESTING TO A REFERENCE AND STATE LABORATORY. BOTH MALDI TOF ASSAYS IDENTIFIED THE ISOLATE AS E.COLI. THE REFERENCE LABORATORY ALSO TESTED THE ISOLATE USING BIOCHEMICAL TESTS, WHICH ALSO IDENTIFIED THE ISOLATE AS E.COLI. THE CUSTOMER STATED THAT ALTHOUGH TREATMENT WAS PROVIDED FOR THE INCORRECT IDENTIFICATION RESULT, THE TREATMENT WAS EFFECTIVE AND NO MEDICAL INTERVENTION WAS REQUIRED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146265 ↗
• MalfunctionJul 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF SHIGELLA SONNEI AS SALMONELLA ENTERICA SSP DIARIZONIA WHEN TESTING A (B)(6) SURVEY SAMPLE WITH THE VITEK® 2 GN ID TEST KIT (REF. 21341, LOT 2410762203). THE EXPECTED IDENTIFICATION FOR THE CAP SURVEY SAMPLE IS SHIGELLA SP OR SHIGELLA SONNEI. REPEAT TESTING USING THE VITEK 2 GN ID TEST KIT IDENTIFIED THE SAMPLE AS SALMONELLA ENTERICA SSP DIARIZONIA. THE CUSTOMER PERFORMED ANALYTICAL PROFILE INDEX (API) AND BIOFIRE® FILMARRAY® TESTING AND THE SAMPLE WAS IDENTIFIED AS SHIGELLA. AS THE SAMPLE WAS FROM A (B)(6) SURVEY, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8841089 ↗
• MalfunctionJul 29, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "ANALYSIS ON BRUCELLOSIS EPIDEMIOLOGICAL CHARACTERISTICS IN HAINAN PROVINCE" BY WANG XM, ET AL. THE PUBLICATION NOTED ONE (1)MISIDENTIFICATION OF BRUCELLA MELITENSIS AND FOUR (4) MISIDENTIFICATIONS OF BRUCELLA SUIS AS OCHROBACTRUM ANTHROPI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT, USING SOFTWARE VERSION (B)(4). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF VITEK 2 GN ID TEST KIT USED. TRADITIONAL BIOTYPING METHODS IDENTIFIED ELEVEN (11) STRAINS AS BRUCELLA MELITENSIS BIOVAR 3, AND FIVE (5) STRAINS AS BRUCELLA SUIS BIOVAR 3. THERE IS NO INDICATION FROM THE PUBLICATION 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 8838773 ↗
• MalfunctionJun 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF SHIGELLA SONNEI (NEQAS DISTRIBUTION 4486, SPECIMEN 5012) AS PLURALIBACTER GERGOVIAE IN ASSOCIATION WITH THE VITEK® 2 GRAM NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE IDENTIFICATION TO SHIGELLA SONNEI WAS CONFIRMED VIA VITEK MS TESTING FOLLOWED BY SHIGELLA LATEX.. THERE WAS NO GN ID REPEAT TESTING FOR THIS NEQAS STRAIN. THE CUSTOMER STATED THAT THERE WAS NO ADVERSE IMPACT TO ANY PATIENT'S STATE OF HEALTH; THE NEQAS STRAIN WAS NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8745175 ↗
• MalfunctionJun 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF A SHIGELLA SONNEI PATIENT TRAIN AS PLURALIBACTER GERGOVIAE IN ASSOCIATION WITH THE VITEK® 2 GRAM NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING OBTAINED THE SAME RESULT. THE IDENTIFICATION TO SHIGELLA SONNEI WAS CONFIRMED VIA VITEK MS TESTING FOLLOWED BY SHIGELLA LATEX.. THE CUSTOMER STATED THAT THE DISCREPANT GN ID RESULT WAS NOT REPORTED TO THE TREATING PHYSICIAN, AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8745173 ↗
• InjuryMay 24, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INJURIES FOR THREE EMPLOYEES, IN ASSOCIATION WITH THE USE OF THE VITEK® 2 GN ID TEST KIT (REFERENCE 21341). THE LOT NUMBERS FOR THE VITEK 2 CARDS ASSOCIATED WITH THIS REPORT WERE NOT PROVIDED. THE CUSTOMER HAS REPORTED THAT EMPLOYEES COMPLAIN OF PAIN FROM OPENING THE VITEK 2 CARD POUCHES AND HAVE INCURRED SICK LEAVES DUE TO THE FREQUENT OPENING OF THE VITEK 2 CARD POUCHES (NO MATTER THE CARD TYPE). THE CUSTOMER STATED THAT APPROXIMATELY 240 VITEK 2 CARD POUCHES ARE OPENED PER DAY; SOME DAYS UP TO 300 CARDS ARE OPENED AND USED. THE CUSTOMER INDICATED THAT CONSIDERABLY MORE STRENGTH IS NECESSARY THAN WITH THE PREVIOUS FOIL CARD POUCHES. IN ADDITION THE NOTCHES ARE OFTEN NOT BIG ENOUGH, SO EVEN MORE STRENGTH IS NEEDED TO OPEN THE CARD POUCHES. THE CUSTOMER ALSO STATED THE TEAR OF THE POUCH IS OFTEN NOT PARALLEL TO THE EDGE. THEREFORE, ONLY ONE CORNER OF THE POUCH IS OPEN AND THIS OFTEN HAPPENS ON THE OTHER CORNER AS WELL. CONSEQUENTLY TWO CORNERS ARE GONE, BUT ONE STILL CANNOT TAKE THE CARD FROM THE POUCH. THE CUSTOMER CLAIMS THAT, AS A CONSEQUENCE, THREE (3) COWORKERS HAVE BEEN IMPACTED. THE EMPLOYEE ASSOCIATED WITH THIS MEDWATCH REPORT REP

  Patient problems: Injury

  MAUDE report 8639956 ↗
• InjuryMay 24, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN INJURY REQUIRING SURGERY, AND CLAIMING THAT REPETITIVE OPENING OF VITEK® 2 GN ID TEST KITS (REFERENCE 21341) MAY HAVE CONTRIBUTED TO THE INJURY. THE CUSTOMER COMPLAINED ABOUT PAIN IN THE THUMBS AND FOREARMS WHEN OPENING THE VITEK 2 CARD POUCHES. THE CUSTOMER REPORTS A STRONG CORRELATION BETWEEN THE NEW CARD POUCHES, AND THE DEVELOPMENT OF A GANGLION IN HER RIGHT HAND. THE CUSTOMER REPORTED THAT THE VITEK 2 CARD POUCHES CHANGED APPROXIMATELY TWO YEARS AGO, AND THAT THE NEW POUCHES ARE DIFFICULT TO OPEN, AND CAUSE PAIN WHEN OPENED FREQUENTLY. THE CUSTOMER REPORTED OPENING APPROXIMATELY FIFTY (50) VITEK 2 CARD POUCHES PER DAY. THE CUSTOMER HAS REPORTED THAT, SIX (6) MONTHS AFTER THE NEW CARD POUCHES WERE INTRODUCED TO THE CUSTOMER (THE PATIENT), SHE DEVELOPED A GANGLION IN THE RIGHT HAND. THE CUSTOMER REPORTED THAT THE GANGLION GREW LARGER AND MORE PAINFUL BECAUSE OF THE WORKLOAD - THE GANGLION WAS SURGICALLY REMOVED IN (B)(6) 2019. THE CUSTOMER (PATIENT) REPORTS THAT SHE HAS BEEN WORKING IN THE SAME LAB FOR SIX (6) YEARS, AND NEVER HAD THESE ISSUES BEFORE; AFTER THE PREVIOUS FOIL POUCHES OF THE VITEK 2 CARDS CHANGED, SHE DEVELOPED A GANG

  Patient problems: Injury

  MAUDE report 8639955 ↗
• InjuryMay 24, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INJURIES FOR THREE EMPLOYEES, IN ASSOCIATION WITH THE USE OF THE VITEK® 2 GN ID TEST KIT (REFERENCE 21341). THE LOT NUMBERS FOR THE VITEK 2 CARDS ASSOCIATED WITH THIS REPORT WERE NOT PROVIDED. THE CUSTOMER HAS REPORTED THAT EMPLOYEES COMPLAIN OF PAIN FROM OPENING THE VITEK 2 CARD POUCHES AND HAVE INCURRED SICK LEAVES DUE TO THE FREQUENT OPENING OF THE VITEK 2 CARD POUCHES (NO MATTER THE CARD TYPE). THE CUSTOMER STATED THAT APPROXIMATELY 240 VITEK 2 CARD POUCHES ARE OPENED PER DAY; SOME DAYS UP TO 300 CARDS ARE OPENED AND USED. THE CUSTOMER INDICATED THAT CONSIDERABLY MORE STRENGTH IS NECESSARY THAN WITH THE PREVIOUS FOIL CARD POUCHES. IN ADDITION THE NOTCHES ARE OFTEN NOT BIG ENOUGH, SO EVEN MORE STRENGTH IS NEEDED TO OPEN THE CARD POUCHES. THE CUSTOMER ALSO STATED THE TEAR OF THE POUCH IS OFTEN NOT PARALLEL TO THE EDGE. THEREFORE, ONLY ONE CORNER OF THE POUCH IS OPEN AND THIS OFTEN HAPPENS ON THE OTHER CORNER AS WELL. CONSEQUENTLY TWO CORNERS ARE GONE, BUT ONE STILL CANNOT TAKE THE CARD FROM THE POUCH. THE CUSTOMER CLAIMS THAT, AS A CONSEQUENCE, THREE (3) COWORKERS HAVE BEEN IMPACTED. THE EMPLOYEE ASSOCIATED WITH THIS MEDWATCH REPORT (19

  Patient problems: Injury

  MAUDE report 8639954 ↗
• InjuryMay 24, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INJURIES FOR THREE EMPLOYEES, IN ASSOCIATION WITH THE USE OF THE VITEK® 2 GN ID TEST KIT (REFERENCE 21341). THE LOT NUMBERS FOR THE VITEK 2 CARDS ASSOCIATED WITH THIS REPORT WERE NOT PROVIDED. THE CUSTOMER HAS REPORTED THAT EMPLOYEES COMPLAIN OF PAIN FROM OPENING THE VITEK 2 CARD POUCHES AND HAVE INCURRED SICK LEAVES DUE TO THE FREQUENT OPENING OF THE VITEK 2 CARD POUCHES (NO MATTER THE CARD TYPE). THE CUSTOMER STATED THAT APPROXIMATELY 240 VITEK 2 CARD POUCHES ARE OPENED PER DAY; SOME DAYS UP TO 300 CARDS ARE OPENED AND USED. THE CUSTOMER INDICATED THAT CONSIDERABLY MORE STRENGTH IS NECESSARY THAN WITH THE PREVIOUS FOIL CARD POUCHES. IN ADDITION THE NOTCHES ARE OFTEN NOT BIG ENOUGH, SO EVEN MORE STRENGTH IS NEEDED TO OPEN THE CARD POUCHES. THE CUSTOMER ALSO STATED THE TEAR OF THE POUCH IS OFTEN NOT PARALLEL TO THE EDGE. THEREFORE, ONLY ONE CORNER OF THE POUCH IS OPEN AND THIS OFTEN HAPPENS ON THE OTHER CORNER AS WELL. CONSEQUENTLY TWO CORNERS ARE GONE, BUT ONE STILL CANNOT TAKE THE CARD FROM THE POUCH. THE CUSTOMER CLAIMS THAT, AS A CONSEQUENCE, THREE (3) COWORKERS HAVE BEEN IMPACTED. THE EMPLOYEE ASSOCIATED WITH THIS MEDWATCH REPORT REP

  Patient problems: Injury

  MAUDE report 8639951 ↗
• InjuryApr 30, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EMPLOYEE INJURIES IN ASSOCIATION WITH THE USE OF VITEK® 2 GN TEST KIT (REFERENCE 21341 LOT 2410770203). THIS HIGH THROUGHPUT CUSTOMER OPENS APPROXIMATELY 400 CARD POUCHES A PER DAY AND HAS STATED THAT THE POUCHES HAVE BECOME DIFFICULT TO OPEN AND RESULTED IN EMPLOYEE INJURIES. SPECIFICALLY, THE CUSTOMER ALLEGED THEY HAVE HAD TWO EMPLOYEES OUT FOR FOUR WEEKS FOR SEVEN WEEKS OF WORK RESPECTIVELY OF WORK (FOR FOUR WEEKS AND SEVEN WEEKS, RESPECTIVELY) DUE TO FOREARM INJURIES THAT REQUIRED SPLINTS. THE CUSTOMER CONFIRMED THAT THEY WERE TEARING THE POUCHES OPEN USING THE NOTCHES IN THE PACKAGING PER THE INSTRUCTIONS FOR USE BUT ARE NOW USING SCISSORS TO OPEN THE POUCHES. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: Injury; Pain

  MAUDE report 8565233 ↗
• InjuryApr 30, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EMPLOYEE INJURIES IN ASSOCIATION WITH THE USE OF VITEK® 2 GN TEST KIT (REFERENCE 21341, LOT 2410770203). THIS HIGH THROUGHPUT CUSTOMER OPENS APPROXIMATELY 400 CARD POUCHES A PER DAY AND HAS STATED THAT THE POUCHES HAVE BECOME DIFFICULT TO OPEN AND RESULTED IN EMPLOYEE INJURIES. SPECIFICALLY, THE CUSTOMER ALLEGED THEY HAVE HAD TWO EMPLOYEES OUT FOR FOUR WEEKS FOR SEVEN WEEKS OF WORK RESPECTIVELY OF WORK (FOR FOUR WEEKS AND SEVEN WEEKS, RESPECTIVELY) DUE TO FOREARM INJURIES THAT REQUIRED SPLINTS. THE CUSTOMER CONFIRMED THAT THEY WERE TEARING THE POUCHES OPEN USING THE NOTCHES IN THE PACKAGING PER THE INSTRUCTIONS FOR USE BUT ARE NOW USING SCISSORS TO OPEN THE POUCHES. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: Injury; Pain

  MAUDE report 8565229 ↗
• MalfunctionJan 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL PUBLICATION REVIEW OF THE ARTICLE "KLEBSIELLA GRIMONTII, A NEW SPECIES ACQUIRED CARBAPENEM RESISTANCE," BY LU LIU, YU FENG, YIYI HU, MEI KANG, YI XIE, AND ZHIYONG ZONG, NOTED THE MISIDENTIFICATION OF THE NEWLY IDENTIFIED KLEBSIELLA GRIMONTII SPECIES AS KLEBSIELLA OXYTOCA WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT. IT SHOULD BE NOTED THAT THIS NEW SPECIES IS NOT CLAIMED IN THE VITEK 2 GN ID KNOWLEDGE BASE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS JOURNAL ARTICLE STUDY, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8261583 ↗
• MalfunctionNov 7, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED DISCREPANT IDENTIFICATION RESULTS IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT AND VITEK 2 SYSTEMS SOFTWARE 8.01. THE CUSTOMER REPORTED THAT AN ISOLATE WAS IDENTIFIED AS SHIGELLA SONNEI (99.9%) WITH VITEK, AND ESCHERICHIA COLI (94%) WITH API® 20E. THE CUSTOMER THEN RAN PCR (BD MAX) AND OBTAINED SHIGA TOXIN. THE SPECIMEN WAS THEN SENT TO A REFERENCE LAB. THE RESULT OF SHIGA TOXIN WAS REPORTED TO THE CLINICIAN. THE CUSTOMER DID NOT KNOW IF PATIENT TREATMENT WAS IMPACTED. 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 8048673 ↗
• MalfunctionOct 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY STRAIN (D-09) AS MORAXELLA GROUP WITH THE VITEK® 2 GN TEST KIT (2410478203). THE CUSTOMER REPORTED A RESULT OF MORAXELLA GROUP AND FOUND OUT LATER THAT THE EXPECTED RESULT WAS ACINETOBACTER LWOFFI, ACINETOBACTER JUNII (LWOFFI/JOHNSONII), OR ACINETOBACTER SP. THE BIOMÉRIEUX LOCAL FIELD APPLICATION SPECIALIST TESTED THE ISOLATE ON THE VITEK SYSTEMS OF THE REPORTING CUSTOMER AND ANOTHER CUSTOMER, AND THE RESULT WAS MORAXELLA GROUP. THE ISOLATE WAS IDENTIFIED AS ACINETOBACTER LWOFFII WITH VITEK MS.

  Patient problems: No Patient Involvement

  MAUDE report 8025947 ↗
• MalfunctionOct 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR A KLEBSIELLA PNEUMONIAE EQA STRAIN WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT (REF 21341). THE GN CARD PROVIDED NO IDENTIFICATION (NON-REACTIVE BIOPATTERN) AND THEN AN INCORRECT IDENTIFICATION (METHYLOBACTERIUM SPP.). THE STRAIN WAS RETESTED USING BRUKER MALDI-TOF AND IDENTIFIED AS KLEBSIELLA PNEUMONIAE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7982341 ↗
• MalfunctionOct 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR A PROVIDENCIA STUARTII EQA STRAIN WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT (REF 21341). THE GN CARD PROVIDED AN IDENTIFICATION OF AEROMONAS SALMONICIDA. THE STRAIN WAS RETESTED USING BRUKER MALDI-TOF AND IDENTIFIED AS PROVIDENCIA STUARTII. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7982299 ↗
• MalfunctionOct 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT (REF 21341). A PATIENT STRAIN WAS IDENTIFIED AS PROVIDENCIA RUSTIGIANII USING THE VITEK 2 GN CARD, LOT: 2410578203, WITH INITIAL AND REPEAT TESTING. WHEN THE CUSTOMER PERFORMED THE IDENTIFICATION WITH API, IT IDENTIFIED THE STRAIN AS PROVIDENCIA STUARTII. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7974209 ↗
• MalfunctionOct 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF A URINE SAMPLE KLEBSIELLA PNEUMONIAE AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION ID) TEST KIT. A BLOOD CULTURE RESULT FROM THE SAME PATIENT PROVIDED THE KLEBSIELLA PNEUMONIAE RESULT. RETEST OF THE URINE SAMPLE OBTAINED AN ORGANISM IDENTIFICATION TO KLEBSIELLA PNEUMONIAE AS WELL. THE CUSTOMER STATED THAT PATIENT TREATMENT (ROCEPHIN) WAS BASED ON THE BLOOD CULTURE RESULT. THE INITIAL RESULT OF K. OXYTOCA FROM THE URINE SAMPLE WAS NOT USED IN THE PATIENT THERAPY DECISIONS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955551 ↗
• MalfunctionOct 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII SURVEY SAMPLE (D-9) AS MORAXELLA GROUP IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE CUSTOMER TESTED THE SAMPLE ON THE VITEK GN ID CARD, AND OBTAINED AN IDENTIFICATION OF MORAXELLA GROUP, WHEN THE EXPECTED RESULT WAS ACINETOBACTER LWOFFII.

  Patient problems: No Patient Involvement

  MAUDE report 7954584 ↗
• MalfunctionOct 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY SAMPLE (D-9) AS MORAXELLA GROUP IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE CUSTOMER TESTED THE SAMPLE MULTIPLE TIMES ON THE VITEK GN ID AND THE NH CARD, AND OBTAINED AN IDENTIFICATION OF MORAXELLA GROUP, WHEN THE EXPECTED RESULT WAS ACINETOBACTER LWOFFII.

  Patient problems: No Patient Involvement

  MAUDE report 7954582 ↗
• MalfunctionSep 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR THE MORAXELLA OSLOENSIS ATCC 19976 STRAIN WHEN TESTING WITH THE VITEK® 2 GN ID CARD (REF 21341). THE GN CARD IDENTIFIED THE SAMPLE AS ACINETOBACTER LOWFFII ON INITIAL TESTING. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7912363 ↗
• MalfunctionSep 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF SHIGELLA BOYDII AS ESCHERCHIA COLI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE CUSTOMER REPORTED THAT A CLINICAL ISOLATE WAS STRICTLY FOR RESEARCH USE, AND WAS FROM A CLINICAL SPECIMEN IN 2014. THE CUSTOMER STATED THAT THEY TESTED THE CLINICAL ISOLATE, QC ISOLATE ATCC 35965 (SHIGELLA BOYDII), AND TWO OTHER ISOLATES (SHIGELLA STRAINS CDPH07 AND CDPH15) FROM A STATE REFERENCE LAB. ALL ISOLATES HAD THE SAME ESCHERCHIA COLI IDENTIFICATION. THE CUSTOMER REPORTED THAT THEY GREW THE ORGANISM IN TSB (TRYPCASE SOY BROTH) , OR BHI (BRAIN HEART INFUSION) THEN STREAKED ONLY ONCE TO THE TSA (TRYPCASE SOY AGAR) BEFORE TESTING THE ISOLATE WITH THE GN ID CARD. BIOMÉRIEUX REQUESTED THAT THE CUSTOMER PERFORM RETESTING OF THE ORGANISM AFTER PERFORMING TWO SUBCULTURES ON A TSA OR TSAB (TRYPTIC SOY AGAR + SHEEP BLOOD). THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A CLINICAL RESEARCH STUDY. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7901911 ↗
• MalfunctionSep 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES REPORTED A MISIDENTIFICATION OF A CAP SURVEY STRAIN WHEN TESTING WITH THE VITEK® 2 GN ID CARD (REF (B)(4)). THE EXPECTED ID WAS ACINETOBACTER LWOFFI. THE GN ID CARD IDENTIFIED THE STRAIN AS MORAXELLA GROUP. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A CAP SURVEY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7897212 ↗
• MalfunctionSep 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY STRAIN (D-09) AS MORAXELLA GROUP IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT (LOT 2410474203). THE CUSTOMER STATED THEY REPORTED THE IDENTIFICATION AS MORAXELLA GROUP AND THE EXPECTED RESULT WAS ACINETOBACTER LWOFFII. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7890169 ↗
• MalfunctionSep 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 GN ID CARD (REFERENCE (B)(4)). THE CUSTOMER REPORTED SALMONELLA ENTERICA SUBSP. ENTERICA SERVOR DIARIZONAE WAS IDENTIFIED WITH GN CARDS. THE CUSTOMER CONSIDERED THIS WAS NOT SALMONELLA ACCORDING TO ANTISERUM AND OTHER TESTING WAS PERFORMED WHICH RESULTED IN CITROBACTER FREUNDII. THE OTHER TESTS WERE PERFORMED WITH TSI MEDIA AND SIM MEDIA, BUT NOT WITH API®, VITEK MS OR 16S. THE CORRECT RESULT OF C. FREUNDII WAS REPORTED TO THE PHYSICIAN. THERE WAS NO DELAY IN REPORTING RESULTS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885702 ↗