BACT/ALERT® FN PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 03573026596071), received between Jul 12, 2017 and Sep 19, 2024 — classified as 9 injuries, 35 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (11 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM PANAMA OF A FALSE POSITIVE BCID2 RESULTS ASSOCIATED WITH BACT/ALERT FN PLUS (PLASTIC) 100 BTLS -REF. 410852, LOT 0004061148. SUMMARY: BCID2: SERRATIA MARCESCENS AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OF THE ALTERNATE METHOD TESTING PERFORMED TO CONFIRM NO PRESENCE OF SERRATIA MARCESCENS. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257672 ↗
• MalfunctionSep 19, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM PANAMA OF A FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT FN PLUS (PLASTIC) 100 BTLS -REF. (B)(4)., LOT 0004061294. SUMMARY: BCID: SERRATIA MARCESCENS AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OF THE ALTERNATE METHOD TESTING PERFORMED TO CONFIRM NO PRESENCE OF SERRATIA MARCESCENS. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY®

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257201 ↗
• MalfunctionSep 18, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM PANAMA OF A FALSE POSITIVE BCID2 RESULTS ASSOCIATED WITH BACT/ALERT FN PLUS (PLASTIC) 100 BTLS -REF. (B)(4), LOT 0004061148. SUMMARY: BCID2: SERRATIA MARCESCENS. AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OF THE ALTERNATE METHOD TESTING PERFORMED TO CONFIRM NO PRESENCE OF SERRATIA MARCESCENS. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246345 ↗
• MalfunctionAug 28, 2024Cross Reactivity; Cross Reactivity

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT FROM PANAMA OF A FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT FN PLUS (PLASTIC) 100 BTLS -REF. 410852, LOT 0004061294. SUMMARY: BCID: SERRATIA MARCESCENS. AT THE TIME OF THIS ASSESSMENT THERE IS NO INDICATION OF THE ALTERNATE METHOD TESTING PERFORMED TO CONFIRM NO PRESENCE OF SERRATIA MARCESCENS. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY®

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083541 ↗
• MalfunctionSep 18, 2023False Negative Result; False Negative Result

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS WHEN USING THE BACT/ALERT FN PLUS (PLASTIC) - 410852 ( LOT# 0004059750- EXPIRATION DATE : 1/21/2024). THIS COMPLAINT IS RELATED TO COMPLAINT (B)(4). (SAME ISSUE, SAME CUSTOMER, DIFFERENT PRODUCT REFERENCE). THE CUSTOMER INDICATED HAVING FOUND TWO POSITIVE BOTTLES (ONE FN PLUS BOTTLE AND ONE FA PLUS BOTTLE) IN THE TRASH OF THE VIRTUO. THESE BOTTLES HAVE NOT BEEN FLAGGED BY THE INSTRUMENT AS POSITIVE. THE SUBCULTURE OF THESE BOTTLES HAS SHOWN A MICROBIAL GROWTH. IN TOTAL FOUR (4) BOTTLES (2 TRUE POSITIVE, 2 FALSE NEGATIVE) FROM THE PATIENT WERE PERFORMED. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE MENTIONED THAT THIS IS NOT AN UNUSUAL OCCURRENCE AS BLOOD STREAM INFECTIONS ARE NOT SPREAD UNIFORMLY IN THE BLOOD SAMPLE. THAT IS WHY RECOMMENDATIONS ARE TO DRAW 20 ML FROM ADULTS SPLIT INTO AEROBIC AND ANAEROBIC BOTTLES, AND TO DRAW MORE THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763674 ↗
• MalfunctionJun 21, 2023Microbial Contamination of Device; Microbial Contamination of Device

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS (POTENTIAL CONTAMINATION) IN ASSOCIATION WITH BACT/ALERT FN PLUS (PLASTIC) (REF. (B)(4), BATCH NUMBER UNKNOWN) WITH A PATIENT SAMPLE. CUSTOMER REPORTED THAT VACUTAINER TUBE WAS NOT TRANSFERRING BLOOD TO ANAEROBIC (FN PLUS) BOTTLES, AND THAT THIS WAS HAPPENING ONLY WITH ANAEROBIC BOTTLES. CUSTOMER SAID THAT THE ISSUE STOPPED AFTER THEY BEGAN USING A NEW LOT OF BOTTLES, BUT THEY DISCARDED THE BOX THAT HAD THE PROBLEMATIC BOTTLES SO THEY DON'T KNOW WHAT LOT NUMBER THEY WERE. IT WAS REPORTED THAT THE CUSTOMER BELIEVES THAT ONE BOTTLE WAS CONSIDERED AS POSITIVE DUE TO CONTAMINATION WHILE DRAWING FROM THE VACUTAINER WITH A SYRINGE. ACCORDING TO BIOMÉRIEUX LOCAL CUSTOMER SERVICE, IT ASSUMED THAT THE BOTTLE WAS CALLED POSITIVE DUE TO CONTAMINATION FROM THE SYRINGE DRAW, BUT THIS IS NOT CONFIRMED. AT THE TIME OF ASSESSMENT, THERE IS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169997 ↗
• MalfunctionMay 22, 2023Microbial Contamination of Device; Microbial Contamination of Device

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A CLINICAL FALSE POSITIVE RESULTS WHEN USING THE BACT/ALERT FN PLUS (PLASTIC) - REFERENCE 410852 ( LOT#0004059812). INDEED, THE CUSTOMER NOTIFIED THAT SIX (6) BOTTLES FROM THE LOT# 0004059808 ( DOCUMENTED IN THE (B)(4)) AND THE LOT#0004059812 ( DOCUMENTED IN THIS COMPLAINT) HAVE BEEN FLAGGED POSITIVE. THEY HAVE BEEN SUBCULTURED AND THE STRAIN IDENTIFIED AS EGGERTHELLA LENTA EUBACTERIUM USING THE VITEK MS INSTRUMENT. FOUR PATIENTS ARE CONCERNED BY THE ISSUE. THE RESULT HAS BEEN PROVIDED TO INFECTIOUS DISEASE DOCTORS WHO BELIEVE THAT THE STRAIN IDENTIFIED IS A CONTAMINANT. INDEED, IT IS SUSPECTED THAT THE ORGANISM REPORTED BY THE CLINICAL LABORATORY WAS NOT PRESENT IN THE PATIENT BUT INTRODUCED INTO TEST AND/OR SAMPLE AT SOME POINT BEFORE OR DURING THE TEST PROCEDURE. ONE PATIENT HAD HIS ANTIBIOTIC TREATMENT CHANGED FOLLOWING THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972563 ↗
• MalfunctionMay 22, 2023Microbial Contamination of Device; Microbial Contamination of Device

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A CLINICAL FALSE POSITIVE RESULTS WHEN USING THE BACT/ALERT FN PLUS (PLASTIC) - REFERENCE 410852 ( LOT#0004059808). INDEED, THE CUSTOMER NOTIFIED THAT SIX (6) BOTTLES FROM THE LOT# 0004059808 AND THE LOT#0004059812 (DOCUMENTED IN THE (B)(6) ) HAVE BEEN FLAGGED POSITIVE. THEY HAVE BEEN SUBCULTURED AND THE STRAIN IDENTIFIED AS EGGERTHELLA LENTA EUBACTERIUM USING THE VITEK MS INSTRUMENT. FOUR PATIENTS ARE CONCERNED BY THE ISSUE. THE RESULT HAS BEEN PROVIDED TO INFECTIOUS DISEASE DOCTORS WHO BELIEVE THAT THE STRAIN IDENTIFIED IS A CONTAMINANT. INDEED, IT IS SUSPECTED THAT THE ORGANISM REPORTED BY THE CLINICAL LABORATORY WAS NOT PRESENT IN THE PATIENT BUT INTRODUCED INTO TEST AND/OR SAMPLE AT SOME POINT BEFORE OR DURING THE TEST PROCEDURE. ONE PATIENT HAD HIS ANTIBIOTIC TREATMENT CHANGED FOLLOWING THE RESULT. NO INFORMATION HAVE BEEN PROVIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972544 ↗
• MalfunctionMay 22, 2023Microbial Contamination of Device; Microbial Contamination of Device

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A CLINICAL FALSE POSITIVE RESULTS WHEN USING THE BACT/ALERT FN PLUS (PLASTIC) - REFERENCE 410852 ( LOT#0004059808). INDEED, THE CUSTOMER NOTIFIED THAT SIX (6) BOTTLES FROM THE LOT# 0004059808 AND THE LOT#0004059812 ( DOCUMENTED IN THE (B)(6) ) HAVE BEEN FLAGGED POSITIVE. THEY HAVE BEEN SUBCULTURED AND THE STRAIN IDENTIFIED AS EGGERTHELLA LENTA EUBACTERIUM USING THE VITEK MS INSTRUMENT. FOUR PATIENTS ARE CONCERNED BY THE ISSUE. THE RESULT HAS BEEN PROVIDED TO INFECTIOUS DISEASE DOCTORS WHO BELIEVE THAT THE STRAIN IDENTIFIED IS A CONTAMINANT. INDEED, IT IS SUSPECTED THAT THE ORGANISM REPORTED BY THE CLINICAL LABORATORY WAS NOT PRESENT IN THE PATIENT BUT INTRODUCED INTO TEST AND/OR SAMPLE AT SOME POINT BEFORE OR DURING THE TEST PROCEDURE. ONE PATIENT HAD HIS ANTIBIOTIC TREATMENT CHANGED FOLLOWING THE RESULT. NO INFORMATION HAVE BEEN PROVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972543 ↗
• MalfunctionMay 22, 2023Microbial Contamination of Device; Microbial Contamination of Device

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A CLINICAL FALSE POSITIVE RESULTS WHEN USING THE BACT/ALERT FN PLUS (PLASTIC) - REFERENCE (B)(4) ( LOT#0004059808). INDEED, THE CUSTOMER NOTIFIED THAT SIX (6) BOTTLES FROM THE LOT# 0004059808 AND THE LOT#0004059812 ( DOCUMENTED IN THE (B)(4) ) HAVE BEEN FLAGGED POSITIVE. THEY HAVE BEEN SUBCULTURED AND THE STRAIN IDENTIFIED AS EGGERTHELLA LENTA EUBACTERIUM USING THE VITEK MS INSTRUMENT. FOUR PATIENTS ARE CONCERNED BY THE ISSUE. THE RESULT HAS BEEN PROVIDED TO INFECTIOUS DISEASE DOCTORS WHO BELIEVE THAT THE STRAIN IDENTIFIED IS A CONTAMINANT. INDEED, IT IS SUSPECTED THAT THE ORGANISM REPORTED BY THE CLINICAL LABORATORY WAS NOT PRESENT IN THE PATIENT BUT INTRODUCED INTO TEST AND/OR SAMPLE AT SOME POINT BEFORE OR DURING THE TEST PROCEDURE. ONE PATIENT HAD HIS ANTIBIOTIC TREATMENT CHANGED FOLLOWING THE RESULT. NO INFORMATION HAVE BEEN PROVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972542 ↗
• MalfunctionDec 22, 2022False Positive Result; Contamination /Decontamination Problem; False Positive Result; Contamination /Decontamination Problem

  PRODUCT DESCRIPTION: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBSERVED WHAT THEY DESCRIBED AS POTENTIAL CONTAMINATION WHEN TESTING BLOOD CULTURES FROM A PATIENT'S SAMPLE USING BACT/ALERT FN PLUS (PLASTIC) (REF (B)(4), LOT 0004058644, EXPIRATION DATE 08-APR-2023) IN CONJUNCTION WITH THEIR VIRTUO® SYSTEM. THE CUSTOMER SAID THAT THEY HAD INOCULATED A BLOOD SAMPLE FROM ONE PATIENT INTO BACT/ALERT FN PLUS (PLASTIC) BOTTLE, AND THAT AFTER INCUBATION THIS BOTTLES WAS FLAGGED AS "POSITIVE". THE CUSTOMER MENTIONED THAT THEY HAD PROCEEDED WITH SMEAR AND SUBCULTURE OF THE POSITIVE BOTTLES, AND THAT THEY HAD CONFIRMED THE PRESENCE OF CLOSTRIDIUM PERFRINGENS USING VITEK MS TECHNIQUE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE CONCERNED PATIENT. THE CUSTOMER REPORTED THAT THEY HAD OBS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032419 ↗
• MalfunctionDec 22, 2022False Positive Result; Contamination /Decontamination Problem; False Positive Result; Contamination /Decontamination Problem

  PRODUCT DESCRIPTION: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. COMPLAINT DESCRIPTION: A CUSTOMER IN THE UNITED STATES COMPLAINED AFTER HAVING OBSERVED WHAT THEY DISCRIBED AS POTENTIAL CONTAMINATION WHEN TESTING BLOOD CULTURES FROM A PATIENT'S SAMPLE USING BACT/ALERT FN PLUS (PLASTIC) (REF (B)(4) LOT 0004058502, EXPIRATION DATE 08-APR-2023) IN CONJUNCTION WITH THEIR VIRTUO® SYSTEM. THE CUSTOMER SAID THAT THEY HAD INOCULATED A BLOOD SAMPLE FROM ONE PATIENT INTO TWO BACT/ALERT FN PLUS (PLASTIC) BOTTLES (NR0RXY4X AND NR0S3PFK), AND THAT AFTER INCUBATION THESE BOTTLES WERE FLAGGED AS "POSITIVE". THE CUSTOMER MENTIONED THAT THEY HAD PROCEEDED WITH SMEAR AND SUBCULTURE OF THE POSITIVE BOTTLES, AND THAT THEY HAD CONFIRMED THE PRESENCE OF CLOSTRIDIUM PERFRINGENS USING VITEK MS TECHNIQUE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE CONCERNED PATIENT. THE CUSTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032404 ↗
• MalfunctionApr 15, 2022False Positive Result; Contamination /Decontamination Problem; False Positive Result; Contamination /Decontamination Problem

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN INCREASE IN THE NUMBER OF CONTAMINATIONS OBSERVED AFTER INOCULATION IN ASSOCIATION WITH THE BACT/ALERT® FN PLUS (PLASTIC) (REF 410852). THE CUSTOMER HAS NOT YET PROVIDED THE LOT NUMBERS OF THE BOTTLES THAT WERE INDICATED AS CONTAMINATED. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, PRODUCT BACT/ALERT FA PLUS (PLASTIC) (REF 410851) AND TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, PRODUCT BACT/ALERT PF PLUS (PLASTIC) (REF (410853). THE CUSTOMER REPORTED THAT ELEVEN (11) POSITIVE FN PLUS BOTTLES WERE DETERMINED TO CONTAIN CONTAMINANTS. THE CONTAMINANTS THAT THE CUSTOMER IS REPORTING ARE SKIN CONTAMINANTS. THE SOURCE FOR THE CONTAMINANTS HAS NOT YET BEEN DETERMINED. THE CUSTOMER IS FOLLOWING UP WITH THEIR OTHER VENDORS TO INVESTIGATE OTHER PRODUCTS THAT THEY USE IN BLOOD CULTURE COLLECTION. THERE IS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117263 ↗
• MalfunctionJul 29, 2021False Negative Result; False Negative Result

  PRODUCT INTENDED USE : BACT/ALERT¿ FN PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM (B)(6) REPORTED THAT HE OBTAINED A FALSE NEGATIVE RESULT WHEN USING THE BACT/ALERT¿ FN PLUS BOTTLE (REF. 410852)  LOT UNKNOWN. THE CUSTOMER REPORTED THAT THE AEROBIC MATE BOTTLE (FA PLUS) WAS FLAGGED POSITIVE AFTER 1.8 HOURS BY THE INSTRUMENT. THE CUSTOMER, THEN, MANUALLY UNLOADED THE FN PLUS BOTTLE AFTER TWO (2) DAYS OF INCUBATION. THE FN PLUS BOTTLE WAS NEGATIVE-TO-DATE AT THAT TIME. THE CUSTOMER SUB-CULTURED BOTH BOTTLES AND OBTAINED GROWTH OF STREPTOCOCCUS DYSGALACTIAE. THE CUSTOMER PROVIDED NO INFORMATION RELATED TO ANY ANTIBIOTIC TREATMENT OF THE PATIENT BEFORE CULTURE BOTTLE COLLECTION. THERE IS NO PATIENT HARM AS THE FA PLUS BOTTLES FLAGGED POSITIVE AS EXPECTED. AS THE CUSTOMER UNLOADED THE FN PLUS BOTTLE MANUALLY BEFORE END OF INCUBATION TIME, IT IS NOT KNOWN IF THE BOTTLE WOULD HAVE BEEN FLAGGED POSITIVE BEFORE THE END OF THE DEFINED INCUBATION PERIOD. THEREFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246213 ↗
• MalfunctionJun 11, 2021Crack; Crack

  INTENDED USE: BACT/ALERT® FN PLUS CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEM IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE PROBLEM: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF ACCIDENTAL BLOOD EXPOSURE DUE TO CRACKED BOTTLE WITH BACT/ALERT FN PLUS (PLASTIC) (REF. 410852, BATCH NUMBER 0004056536, EXPIRATION DATE 03-NOV-2021). IT IS UNDERSTOOD THAT THE CUSTOMER HAD BLOOD ON HER HAND AS SHE WAS NOT WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE), "WHEN TAKING THE CRACKED BOTTLE OUT OF BTA, CUSTOMER HAD A LITTLE BLOOD ON HER HANDS (BECAUSE SHE WAS NOT WEARING A GLOVE) BUT SHE HAD NO WOUNDS ON HER HANDS AND SHE WASHED HER HANDS IMMEDIATELY." IT WAS ALSO REPORTED THAT THE CRACKED BOTTLE WAS FLAGGED AS POSITIVE BUT THAT THE SMEAR AND SUBCULTURE WERE BOTH NEGATIVE AND THE AEROBIC BOTTLE PAIR COLLECTED AT THE SAME TIME WAS ALSO NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S OR USER'S STATE OF HEALTH. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11983471 ↗
• MalfunctionNov 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF CONTAMINATION WITH BACILLUS LICHENIFORMIS IN ASSOCIATION WITH THE BACT/ALERT® FN PLUS CULTURE BOTTLE (REF. 410852, LOT 0004055368) WHILE TESTING BLOOD CULTURE FROM A PATIENT. THE BOTTLE WAS POSITIVE FOR GROWTH AND SUBCULTURED; THE POSITIVE SUBCULTURE IDENTIFIED AS BACILLUS LICHENIFORMIS USING THE MASS SPECTROMETRY TEST METHOD. THE BACILLUS LICHENIFORMIS IDENTIFICATION WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE CONTAMINATION RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10856875 ↗
• MalfunctionApr 27, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DUPLICATE BOTTLE BARCODE IN ASSOCIATION WITH THE BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE (REF. 410852, LOT 4053900). THE CUSTOMER STATED THAT THEY LOADED THE INOCULATED BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE ONTO THE BACT/ALERT® 3D INSTRUMENT; THE INSTRUMENT IMMEDIATELY REGISTERED THE BOTTLE AS NEGATIVE. THE BOTTLE WAS EJECTED UPON IDENTIFYING THE DUPLICATE BOTTLE BARCODE. THE USER MUST RELOAD THE BOTTLE WITH A GENERIC BOTTLE LABEL IN ORDER FOR IT TO BE FULLY PROCESSED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DUPLICATE LABEL OR EARLY BOTTLE EJECTION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10001207 ↗
• MalfunctionAug 17, 2019False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT ® FN PLUS BLOOD CULTURE BOTTLES (REFERENCE 410852, LOT 4052871). THE CUSTOMER STATED BOTH BOTTLES WERE INCUBATED FOR FIVE DAYS AND FLAGGED NEGATIVE. THESE BOTTLES WERE THEN SUB-CULTURED AND WERE POSITIVE FOR GROWTH OF PROPIONIBACTERIUM ACNES (P. ACNES). ALTHOUGH THE CUSTOMER DID FOLLOW THE FIVE DAY INCUBATION PROTOCOL, P. ACNES IS A FASTIDIOUS SLOW GROWING MICROORGANISM WHICH MAY REQUIRE A LONGER INCUBATION PERIOD. THE BOTTLE INSTRUCTIONS FOR USE (IFU) NOTES THIS A LIMITATION OF THE TEST IF FASTIDIOUS MICROORGANISMS ARE SUSPECTED. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8904289 ↗
• MalfunctionAug 17, 2019False Negative Result; False Negative Result

  A CUSTOMER IN POLAND NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT ® FN PLUS BLOOD CULTURE BOTTLES (REFERENCE 410852, LOT 4053043). THE CUSTOMER STATED BOTH BOTTLES WERE INCUBATED FOR FIVE DAYS AND FLAGGED NEGATIVE. THESE BOTTLES WERE THEN SUB-CULTURED AND WERE POSITIVE FOR GROWTH OF PROPIONIBACTERIUM ACNES (P. ACNES). ALTHOUGH THE CUSTOMER DID FOLLOW THE FIVE DAY INCUBATION PROTOCOL, P. ACNES IS A FASTIDIOUS SLOW GROWING MICROORGANISM WHICH MAY REQUIRE A LONGER INCUBATION PERIOD. THE BOTTLE INSTRUCTIONS FOR USE (IFU) NOTES THIS A LIMITATION OF THE TEST IF FASTIDIOUS MICROORGANISMS ARE SUSPECTED. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8904285 ↗
• MalfunctionMay 3, 2019Leak/Splash; Leak/Splash

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OPERATOR EXPOSURE IN ASSOCIATION WITH THE BACT/ALERT® FN PLUS BOTTLE (REF 410852, LOT 4052309). THE IMPACTED FN PLUS BOTTLE WAS INOCULATED WITH PATIENT SAMPLE, AND IT WAS A POSITIVE BOTTLE. THE LABORATORY TECHNICIAN TOOK THE BOTTLE FROM THE SYSTEM AND, BEFORE REACHING THE SAFETY CABINET, IT FELL TO THE GROUND AND EXPLODED. PER THE CUSTOMER REPORT, THE BOTTLE HAD NOT BEEN HIT OR DROPPED. THE TECHNICIAN RECEIVED SPLASHES OF THE BLOOD CULTURE. THE TECHNICIAN QUICKLY CHANGED CLOTHES AND TOOK A SHOWER. PER THE CUSTOMER REPORT, SHE HAS NOT SUFFERED ANY INJURY. AT THE TIME OF THIS ASSESSMENT, THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING PATIENT IMPACT. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579269 ↗
• MalfunctionMar 26, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A CUSTOMER IN (B)(6) REPORTED A BROKEN BACT/ALERT® FN PLUS (LOT 4052409) BLOOD CULTURE BOTTLE IN CELL 1A OF THE INSTRUMENT, THAT HAD LEAKED INTO MULTIPLE CELLS OF ONE ROW. THE INSTRUMENT HAD FLAGGED THE AFFECTED BOTTLE AS POSITIVE AND GRAM STAIN WAS NEGATIVE BACILLUS. A SECOND ANAEROBIC BOTTLE WAS BEING CULTURED FOR THE PATIENT AND THE IDENTIFICATION WAS IN PROCESS. USING GLOVES, THE CUSTOMER WAS ABLE TO RELOCATE ALL AFFECTED BOTTLES IN THE INSTRUMENT AND CLEAN THE INSTRUMENT CELLS. THE 1A AFFECTED CELL WAS DEACTIVATED. THE FIELD SERVICE ENGINEER WAS DISPATCHED TO CLEAN AFFECTED CELLS AND REPLACE THE RACKS. THE CUSTOMER REPORTED THAT THE BOTTOM OF THE BOTTLE WAS BROKEN, BUT IT WAS NOT KNOWN IF THE BOTTLE HAD BEEN DROPPED. 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 Consequences Or Impact To Patient

  MAUDE report 8454115 ↗
• MalfunctionMar 12, 2019Fracture; Fracture

  A CUSTOMER IN (B)(6) REPORTED THAT A BACT/ALERT® FN PLUS BOTTLE CRACKED AND LEAKED IN THE INSTRUMENT. THE BOTTLE FLAGGED POSITIVE AT 0.98 DAYS, AND WHEN IT WAS UNLOADED ON (B)(6) 2019 FROM THE INSTRUMENT, BLOOD LEAKAGE WAS OBSERVED FROM A CRACK ON THE BOTTLE. BLOOD CAME IN CONTACT WITH THE GLOVED HAND OF THE USER WHO WAS ALSO WEARING A LAB COAT. THE USER FOLLOWED THE DECONTAMINATION PROCESS . THE LOT (4051577) OF BOTTLES WAS CHECKED WITH NO OTHER PROBLEMS OBSERVED. THE CUSTOMER REPORTED THAT THE BACTERIA WAS SUCCESSFULLY ISOLATED FROM THIS POSITIVE BOTTLE AND IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE PATIENT HAD ANOTHER BOTTLE TESTED AND THE RESULT WAS THE SAME. THERE WAS DELAY OF TWO DAYS FOR REPORTING RESULTS WHICH ALSO DELAYED THE CORRECT ANTIBIOTIC TREATMENT. 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 8413284 ↗
• MalfunctionFeb 7, 2019False Negative Result; False Negative Result

  A CUSTOMER FROM (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE RESULT WHEN TESTING AN ESCHERICHIA COLI STRAIN FROM A PATIENT ISOLATE ON BACT/ALERT® FN PLUS (PLASTIC) (REF. 410852). THE LOT NUMBER IS UNKNOWN AS THE IMPACTED BOTTLE WAS DISCARDED BY THE CUSTOMER. THE SAMPLE WAS OBTAINED FROM A POST-SURGICAL ABSCESS OF AN (B)(6), FEMALE PATIENT. THE PATIENT WAS NOT ON AN ANTIFUNGAL AT THE TIME OF SAMPLE COLLECTION. THE CUSTOMER STATED THAT THE FALSE NEGATIVE RESULT WITH THE IMPACTED AEROBIC BOTTLE OF BACT/ALERT FN PLUS WAS DISCOVERED BECAUSE THE OTHER BOTTLE (ANAEROBIC) ALARMED WITH ESCHERICHIA COLI (GRAM NEGATIVE). ESCHERICHIA COLI ALSO GREW ON THE PLATES THAT WERE SUB-CULTURED SIMULTANEOUSLY WHEN THE SAMPLE ARRIVED AT THE LABORATORY. THE CUSTOMER CHECKED THE GROWTH CURVE AND FOUND IT TO BE ATYPICAL. ESCHERICHIA COLI GROWTH WAS OBSERVED ON THE PLATE AFTER SUBCULTURE OF THE IMPACTED BOTTLE. THE FINAL IDENTIFICATION OF ESCHERICHIA COLI WAS CONFIRMED USING MALDI-TOF. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT. THE CUSTOMER STATED THAT THERE WAS A DELAY IN REPORTING RESULTS OF 28 HOURS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316737 ↗
• MalfunctionDec 14, 2018Contamination; Contamination

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS ASSOCIATED WITH BACT/ALERT® FN PLUS (REFERENCE 410852). THE CUSTOMER REPORTED THAT ELEVEN BOTTLES WERE IMPACTED BY A POTENTIAL CONTAMINATION ISSUE OF BACILLUS CEREUS SPECIES (5 FA PLUS BOTTLES, 4 FN PLUS BOTTLES AND 2 PF PLUS BOTTLES). 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. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8165993 ↗
• MalfunctionNov 2, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF BOTTLE LEAKAGE FROM A CRACKED BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE (REFERENCE 410852). THE CUSTOMER REPORTED THE BOTTLE WAS INITIALLY EJECTED AND THAT THE CALIBRATOR WAS ALSO EJECTED SOON AFTERWARD. THE CUSTOMER RELOADED THE CALIBRATOR BUT IT WAS EJECTED AGAIN. THE PATIENT BOTTLE THAT WAS EJECTED HAD A CRACK AND THE OPERATOR WHO HANDLED THE BOTTLE DID NOT HAVE GLOVES ON. THE CUSTOMER CONFIRMED THAT AN INCIDENT FORM WAS FILLED OUT AT THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING ANY TREATMENT FOR THE OPERATOR OR ANY IMPACT TO PATIENT RESULTS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8032422 ↗