VITEK 2 COMPACTRecalls & reported problems across all models

We found 3 models of VITEK 2 COMPACT by Biomerieux , Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2019 and Aug 14, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (15 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VITEK 2 COMPACT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 28, 2021Terminated

   bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

   Z-1308-2021 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗

Most reported VITEK 2 COMPACT problems

VITEK 2 COMPACT models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VITEK® 2 COMPACT 27560

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall18 reports
• VITEK® 2 COMPACT 27530

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall5 reports
• VITEK® 2 COMPACT 27415

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall2 reports

Recent VITEK 2 COMPACT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257523 ↗
• MalfunctionApr 14, 2023Failure to Back-Up; Failure to Back-Up

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF RESULT NOT ACCESSIBLE IN ASSOCIATION WITH VITEK 2 COMPACT 15 (REF. (B)(4), SERIAL NUMBER: (B)(4)). THE CUSTOMER REPORTED OBTAINING AN ERROR MESSAGE STATING: "IMPOSSIBLE TO FIND THE ISOLATE OR AN ERROR OCCURRED WHEN RETRIEVING IT". THE PC WAS RESTARTED TWICE, BUT THE ERROR WAS NOT RESOLVED AND RESULT WAS NOT ACCESSIBLE. BIOMÉRIEUX CUSTOMER SERVICE RECOMMENDED THAT THE CUSTOMER RESTART ANALYSIS. THE RESULTS WERE DELAYED BY MORE THAN 24 HOURS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744657 ↗
• MalfunctionDec 1, 2022High Test Results; High Test Results

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON-FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN SPAIN NOTIFIED BIOMERIEUX OF OBTAINING FALSE RESISTANT RESULTS WHEN USING THE VITEK 2 COMPACT 30 - REFERENCE (B)(4) ( SERIAL NUMBER (B)(4)). AT THE MOMENT, IT HAS NOT BEEN NOTIFIED WHICH STRAINS OR ANTIMICROBIALS ARE CONCERNED BY THE FALSE RESISTANT RESULTS. THE CUSTOMER INDICATES THAT ALTERNATE METHOD AND REPEAT TESTING HAVE BEEN PERFORMED TO CONFIRM THE EXPECTED SUSCEPTIBLE RESULTS. 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 DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892743 ↗
• MalfunctionOct 27, 2022Application Program Problem; Application Program Problem

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NONFERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. ISSUE DESCRIPTION: A CUSTOMER IN COLOMBIA NOTIFIED BIOMÉRIEUX OF OBTAINING DELAYED RESULTS GREATER THAN 24 HOURS WHILE USING THE PRODUCT VITEK 2 COMPACT 60 (REF. 27560, SERIAL NUMBER (B)(4)). IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO VIEW THE RESULTS OF A SPECIFIC ISOLATE DUE TO "ERROR - THE ISOLATE COULD NOT BE FOUND OR THERE WAS AN ERROR WHEN RETRIEVING IT" AND IT DOES NOT ALLOW VIEWING THE ISOLATE. THE CUSTOMER WAS REQUIRED TO SET UP A NEW CARD. AS IT WAS REPORTED THAT CUSTOMER HAD TO RE-SUB THE ORGANISM AND THEN SET UP A NEW CARD, IT¿S UNDERSTOOD THAT RESULTS WERE DELAYED GREATER THAN 24 HOURS. ACCORDING TO BIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682896 ↗
• MalfunctionOct 26, 2022Decreased Sensitivity; Decreased Sensitivity

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON-FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF HAVING CARD TERMINATION ISSUES WITH THEIR VITEK 2 COMPACT (REF. 27530, SERIAL NUMBER (B)(4) RESULTING IN DELAY IN REPORTING RESULTS FOR TWENTY (20) PATIENT ISOLATES. THE CUSTOMER STATED ALL CARDS LOADED (B)(6) 2022 WERE TERMINATED DUE TO THE OPTICS BEING OUT OF CALIBRATION. INDIA LOCAL CUSTOMER SERVICE (LCS) HAD THE CUSTOMER CLEAN THE OPTICS AND ALSO CONNECTED TO THE SYSTEM VIA REMOTE DIAGNOSTICS TO CHECK THE OPTICS STATUS. THE OPTICS PASSED THE CAL COMMAND; HOWEVER, THE DAC VALUES WERE LOW. THE VALUES DISPLAYED WITH THE READ COMMAND WERE ALSO LOW. LCS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672240 ↗
• MalfunctionOct 17, 2022Application Program Problem; Application Program Problem

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A SPECIMEN RESULT BEING INACCESSIBLE IN ASSOCIATION WITH VITEK 2 COMPACT 15 (B)(4). CUSTOMER REPORTED THAT THEY OBTAINED A MESSAGE: "THE ISOLATE COULD NOT BE FOUND OR AN ERROR OCCURRED WHEN RETRIEVING IT". THE PC WAS RESTARTED TWICE, BUT THE ERROR WAS NOT RESOLVED AND RESULT WAS NOT ACCESSIBLE. BIOMÉRIEUX CUSTOMER SERVICE RECOMMENDED CUSTOMER TO RESTART ANALYSIS OF THE TEST; THE RESULTS WERE DELAYED BY MORE THAN 24 HOURS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616303 ↗
• MalfunctionMar 9, 2021No Device Output; No Device Output

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MISSING ISOLATE IN ASSOCIATION WITH THE VITEK® 2 COMPACT 30 (REF. 27530, SERIAL NUMBER (B)(4) ), THE VITEK 2 GP ID CARD (REF. 21342, LOT UNKNOWN) AND SOFTWARE VERSION 9.02. THE CUSTOMER OBTAINED A LOW-DISCRIMINATION RESULT AND STATED WHEN THEY TRIED TO OPEN THE ISOLATE RECORD THEY OBTAINED AN ERROR MESSAGE STATED ¿CANNOT FIND THE ISOLATE.¿ THE CUSTOMER RESTARTED THE SYSTEM; THE SAME ERROR MESSAGE WAS OBTAINED WHEN ATTEMPTING TO OPEN THE ISOLATE RECORD. IT IS UNKNOWN IF THE INABILITY TO REVIEW THE ISOLATE RESULTED IN A DELAY OF REPORTING RESULTS. BIOMERIEUX HAS REQUESTED THE CUSTOMER DATA LOGS. 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. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447029 ↗
• MalfunctionNov 25, 2020Communication or Transmission Problem; Communication or Transmission Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN ISSUE WHERE THERAPEUTIC CORRECTIONS (TC) WERE NOT BEING SENT TO LABORATORY INFORMATION SYSTEM (LIS) USING THE VITEK® 2 COMPACT (REFERENCE # 27560, SERIAL # (B)(4)). USER COMPLAINED ABOUT AN HL7 CONNECTION WITH THE LIS WHERE THE THERAPEUTIC CORRECTIONS WERE NOT SENT TO LIS. THEY SAW THAT ONLY NON-EXPERTIZED RESULTS WERE SENT TO LIS INSTEAD OF EXPERTIZED RESULTS. THEY INDICATED THAT NO WRONG RESULTS WERE GIVEN TO THE PHYSICIAN AND THAT SINCE THE BEGINNING OF THIS ISSUE THEY VERIFIED EACH RESULT MANUALLY ON THE LIS UNTIL THEY CAN FIND A SOLUTION. THE EXPERT UNIT WAS ABLE TO RECREATE THIS ISSUE. THEY DETERMINED THAT ANTIBIOTICS WITH A THERAPEUTIC CORRECTION ARE NOT BEING SENT TO THE LIS AS EXPECTED. WHEN ISOLATE RESULTS ARE SENT TO THE LAB INFORMATION SYSTEM (LIS) VIA HL7 FOR THE FIRST TIME, THERE IS NO PROBLEM. HOWEVER, IF THE ISOLATE IS SENT MORE THAN ONCE TO THE LIS, THEN THE SYSTEM DOES NOT SEND THE EXPERTISED (CORRECTED) INTERPRETATION RESULT. THIS IS TRUE FOR ALL CASES OF THERAPEUTIC CORRECTIONS: PHENOTYPE, FORCING RULE, AND BIOLOGIC CORRECTION. A PHYSICIAN MAY NOT REALIZE THAT AN ANTIBIOTIC SHOULD NOT BE USED. FOR CLARIFICATION, THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10901371 ↗
• MalfunctionJan 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEX OF FALSE RESISTANT RESULTS AND DELAYS IN REPORTING RESULTS FOR PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 COMPACT 30 (REF 27530, SERIAL (B)(4)). THE CUSTOMER STATED THAT THE MAJORITY OF THEIR PATIENT ISOLATES WERE OBTAINING RESISTANT RESULTS ON THE VITEK® 2. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT RESULTS OR DELAYS LED TO ANY ADVERSE EVENTS 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 9547285 ↗
• MalfunctionSep 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR (B)(6) WHEN PERFORMING ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) WITH THE VITEK® 2 COMPACT 60 AFTER A SOFTWARE VERSION UPGRADE TO 8.01. THE SPECIFIC AST CARD TYPE AND LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER IS USING THE DISK DIFFUSION METHOD TO VERIFY THE SUSCEPTIBILITY RESULTS FOR (B)(6) ISOLATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126156 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS 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 9100807 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM GREAT BRITAIN REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS 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 9100804 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS 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 9100803 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS 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 9100802 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS 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 9100801 ↗

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