PREVI® COLOR GRAM V2 414292Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03573026415310), received between Nov 29, 2018 and Mar 27, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Unexpected Color; Unexpected Color

  INTENDED USE: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF STAINING ISSUES ASSOCIATED WITH PREVI COLOR GRAM INSTRUMENT V2 - REF. 414292, LOT 414292202374. THE CUSTOMER INDICATED THAT THESE ISSUES HAVE BEEN ONGOING FOR THE LAST YEAR. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618113 ↗
• MalfunctionMar 17, 2023Unexpected Color; Unexpected Color

  INTENDED USE: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING INCORRECT GRAM STAINS, BOTH POSITIVE WHEN EXPECTED IS NEGATIVE AND NEGATIVE WHEN EXPECTED IS POSITIVE ASSOCIATED WITH PREVI COLOR GRAM INSTRUMENT V2 (REF. 414292, (B)(4)). THE CUSTOMER NOTED THAT THIS ISSUE HAS BEEN ONGOING SINCE OBTAINING THE INSTRUMENT IN OCTOBER OF 2022 AND THAT THE SLIDES ARE NOT HOMOGENEOUS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564656 ↗
• MalfunctionMar 7, 2023Unexpected Color; Unexpected Color

  INTENDED USE: THE PREVI® COLOR GRAM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS WITH BIOMÉRIEUX PREVI® COLOR GRAM REAGENTS ONLY. ISSUE DESCRIPTION: A CUSTOMER IN SWEDEN NOTIFIED BIOMÉRIEUX OF A STAINING ISSUE IN ASSOCIATION WITH PREVI COLOR GRAM INSTRUMENT V2 ((B)(4)). CUSTOMER REPORTED HAVING GRAM NEGATIVE BACTERIA INAPPROPRIATELY STAINED BLUE. CUSTOMER HAS NOT USED INSTRUMENT FOR STAINING IN RECENT MONTHS DUE TO STAFF SHORTAGE, SO NO TIME FOR VALIDATION. THEY HAVE USED THE INSTRUMENT WITH EMPTY SLIDES THREE TIMES PER WEEK AND PERFORMED DAILY, WEEKLY AND MONTHLY MAINTENANCE. WHEN THE CUSTOMER STARTED TO STAIN SAMPLES, THEY WERE TOO BLUE. THE CUSTOMER CHANGED ALL NOZZLES; HOWEVER, NO CHANGE IN THE STAINING. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE (GCS) ASKED CUSTOMER THE FOLLOWING QUESTIONS : NAME OF THE STRAIN OF THE STRAIN INVOLVED; SPECIMEN TYPE (BLOOD CULTURE, ISOLATED COLONIES ON PLATES, URINE); IF BLOOD CULTURE, WHICH REFERENCE AND SUPPLIER NAME. AT THE TIME OF ASSESSMENT, THE CUSTOMER HAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493910 ↗
• MalfunctionMar 1, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  PRODUCT DESCRIPTION: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS. COMPLAINT DESCRIPTION: A CUSTOMER IN FRANCE COMPLAINED AFTER HAVING OBSERVED INCORRECT GRAM STAINING TEST RESULTS WHEN USING THE PREVI® COLOR GRAM (REFERENCE (B)(4), SERIAL NUMBER (B)(4). THE CUSTOMER SAID THAT SINCE SEVEN MONTHS, THEY HAD OBTAINED IN SEVERAL INSTANCES GRAM POSITIVE RESULTS INSTEAD OF GRAM NEGATIVE FOR MICROOGANISMS ISOLATED FROM URINE SAMPLES. THE CUSTOMER MENTIONED THAT SOME TIMES THEY HAD OBSERVED THE SAME ISSUE WITH MICROOGANISM ISOLATED FROM BLOOD SAMPLES. THE CUSTOMER SAID THAT NO INCORRECT GRAM STAINING RESULTS WERE OBTAINED WITH THEIR SECOND PREVI COLOR INSTRUMENT. THE CUSTOMER STATES THAT NO INCORRECT GRAM STAINING RESULTS WERE REPORTED TO A PHYSICIAN. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458449 ↗
• MalfunctionDec 16, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  INTENDED USE: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS. A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NON-HOMOGENEOUS GRAM STAINING WHEN USING THE PREVI® COLOR GRAM (REFERENCE NUMBER AND SERIAL NUMBER: (B)(4)). THE CUSTOMER HAS REPORTED HAVING OBTAINED NON-HOMOGENEOUS COLOR INCLUDING POSITIVE AND NEGATIVE GRAM STAINING WITH NO COLOR. 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 DISCREPANCY WAS REVIEWED FOR VIGILANCE REPORTING ACCORDING TO 21 CFR 803 CONCERNING MEDICAL DEVICE REPORTING. THIS REVIEW HAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. ALTHOUGH THIS EVENT DOES NOT ALLEGE THAT DEATH OR SERIOUS INJURY ACTUALLY OCCURRED, IT HAS BEEN DETERMINED THAT THERE IS POTENTIAL FOR SERIOUS INJURY SHOULD THE SITUATION RECUR WHILE TESTING A PATIENT ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996060 ↗
• MalfunctionDec 2, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  INTENDED USE: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS DESCRIPTION OF THE ISSUE: A CUSTOMER IRELAND NOTIFIED BIOMÉRIEUX OF OBTAINING AN INCORRECT GRAM STAINING WHEN USING THE PREVI® COLOR GRAM (REFERENCE 414292, SERIAL NUMBER# (B)(4)). THE CUSTOMER HAS REPORTED HAVING OBTAINED PINK GRAM POSITIVE BACTERIA INSTEAD OF PURPLE COLONIES. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907250 ↗
• MalfunctionJul 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: THE PREVI® COLOR GRAM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS WITH BIOMÉRIEUX PREVI® COLOR GRAM REAGENTS. ISSUE DESCRIPTION: A CUSTOMER IN UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF A STAINING ISSUE IN ASSOCIATION WITH PREVI COLOR GRAM INSTRUMENT V2 REF. 414292, SERIAL NUMBER (B)(4). CUSTOMER REPORTED HAVING PROBLEMS WITH THE INCORRECT COLOR PRESENTATION; PREVI COLOR SLIDES COMING OUT AS GRAM NEGATIVE BUT SHOULD BE GRAM POSITIVE. AT THE TIME OF ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14889665 ↗
• MalfunctionMay 24, 2022False Negative Result; False Negative Result

  INTENDED USE: THE PREVI® COLOR GRAM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN VITRO DIAGNOSTICS WITH BIOMÉRIEUX PREVI® COLOR GRAM REAGENTS ONLY. ISSUE DESCRIPTION: A CUSTOMER IN DENMARK NOTIFIED BIOMÉRIEUX OF A STAINING ISSUE WITH A GRAM POSITIVE COCCI STRAIN PRESENTING AS GRAM NEGATIVE IN ASSOCIATION WITH PREVI COLOR GRAM INSTRUMENT V2 (REF. 414292, SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THE OBSERVED COLORS WERE INCORRECT FOR THE COCCI SAMPLE; A RESULT OF GRAM NEGATIVE WAS ACHIEVED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490692 ↗
• MalfunctionSep 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: THE PREVI® COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN-VITRO DIAGNOSTICS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING ERRONEOUS GRAM STAIN RESULTS USING PREVI COLOR GRAM INSTRUMENT V2 - (REFERENCE 414292, SERIAL NUMBER : #(B)(4)) FOR SEVERAL STRAINS. - E. COLI : VIOLET / PINK (VARIABLE) INSTEAD OF PINK (GRAM NEGATIVE), - CLOSTRIDIUM SPOROGENES : PINK INSTEAD OF VIOLET (GRAM POSITIVE), - BACILLUS SUBTILIS : PINK / VIOLET (VARIABLE) INSTEAD OF VIOLET (GRAM POSITIVE). THE CUSTOMER NOTICED THAT HE HAD FOLLOWED THE WRONG MAINTENANCE PROCEDURE BEFORE USING THE INSTRUMENT. MOREOVER, THE VOLUME TEST AND THE PATTERN TEST FAILED. CONSEQUENTLY, THE NOZZLES WERE CHANGED AND THE LINE OF CRYSTAL VIOLET WAS FLUSHED. THEN, THE CUSTOMER PERFORMED REPEAT TESTING. HOWEVER, HE STILL OBTAINED NEGATIVE GRAM STAIN FOR CLOSTRIDIUM SPOROGENES WHILE THE EXPECTED RESULTS WAS POSITIVE GRAM STAIN. THE VOLUME TEST WAS PERFORMED AGAIN AND THE RESULTS WERE OUTSIDE THE TOLERANCE RANGE: CRYSTAL VIOLET <9ML. NO PATIENT IMPACT HAS BEEN REPORTED AS A CONSEQUENCE OF THE ERRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480182 ↗
• MalfunctionJul 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: THE PREVI¿ COLOR GRAM HAS BEEN DESIGNED TO PERFORM AUTOMATED GRAM STAINING OF PURE STRAIN ISOLATE SMEARS AND HUMAN SPECIMENS WITH MICROORGANISMS FOR IN-VITRO DIAGNOSTICS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING INCORRECT GRAM STAIN RESULTS WHEN USING THE PREVI¿ COLOR GRAM (REFERENCE 414292, SERIAL NUMBER # (B)(4)). THE CUSTOMER REPORTED GRAM NEGATIVE BACTERIA IS STAINING BLUE INSTEAD OF RED COLONIES. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211636 ↗
• MalfunctionMay 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A DISCREPANT GRAM STAIN RESULT IN ASSOCIATION WITH THE PREVI® COLOR GRAM INSTRUMENT (REF. 414292, SERIAL# (B)(4)) WHEN TESTING A QUALITY CONTROL (QC) ESCHERICHIA COLI STRAIN. THE CUSTOMER STATED THEY TESTED STAPHYLOCOCCUS AUREUS AND E. COLI STRAINS AND BOTH APPEARED PURPLE/BLUE IN COLOR. THE CUSTOMER CONFIRMED THE EXPECTED GRAM STAIN RESULT FOR THE E. COLI ISOLATE WAS PINK. TROUBLESHOOTING ACTIVITIES WITH BIOMERIEUX CUSTOMER SERVICE DID NOT IDENTIFY ANY USER ERROR AND HAVE REQUESTED THE CUSTOMER SUBMIT THE IMPACTED STRAIN. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896180 ↗
• MalfunctionApr 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING AN INCORRECT GRAM STAIN RESULT IN ASSOCIATION WITH THE PREVI® COLOR GRAM INSTRUMENT (REF. 414292, SERIAL # (B)(4)) WHEN TESTING A PATIENT BLOOD CULTURE SAMPLE. THE CUSTOMER STATED THAT THEY OBSERVED GRAM NEGATIVE BACTERIA WHICH WERE PURPLE IN COLOR ON ONE SIDE OF THE SLIDE. HOWEVER, ON THE OTHER SIDE OF THE SLIDE, THE GRAM NEGATIVE BACTERIA ARE PINK. A GRAM POSITIVE RESULT WAS INITIALLY PROVIDED TO THE TREATING CLINICIAN; HOWEVER, THE CORRECT GRAM NEGATIVE RESULT WAS PROVIDED TO THE CLINICIAN THE SAME MORNING APPROXIMATELY THREE AND A HALF HOURS LATER. 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 HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604157 ↗
• MalfunctionFeb 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A GRAM STAINING ISSUE IN ASSOCIATION WITH THEIR PREVI COLOR® V2 INSTRUMENT REF. 414292, SERIAL NUMBER (B)(4). THE CUSTOMER STATED ALL SAMPLES TESTED USING THEIR PREVI COLOR® V2 INSTRUMENT OBTAINED A NEGATIVE GRAM STAIN RESULT. THE CUSTOMER CONFIRMED THE DECOLORIZER USED WAS MEDICAL ALCOHOL AND THAT THEY ADJUSTED THE DECOLORIZER LEVELS. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND PERFORMED NOZZLE MAINTENANCE, PATTERN TEST, AND VOLUME TEST. NO ISSUES WERE NOTED. THERE IS NO ADVERSE PATIENT IMPACT. THE CUSTOMER CONFIRMED MANUAL GRAM STAINS WERE PERFORMED TO CONFIRM ANY QUESTIONABLE RESULTS. NO INCORRECT RESULTS WERE REPORTED TO THE TREATING PHYSICIAN. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11353122 ↗
• MalfunctionDec 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF INCORRECT STAINING RESULTS IN ASSOCIATION WITH THE PREVICOLOR® GRAM INSTRUMENT V2 (REF. 414292, SERIAL NUMBER (B)(4)) WHILE STAINING PATIENT URINE SAMPLES. THE CUSTOMER USED 10¿L OF URINE SAMPLE WHEN PREPARING THE PREVICOLOR® GRAM SLIDES. THE SAMPLES WAS THEN ADHERED TO THE SLIDES USING AIR DRY AND BURNER FIXATION METHODS. THE CUSTOMER STATED GRAM POSITIVE SAMPLES APPEARED PINK IN COLOR. BIOMERIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO INCREASE THE SAMPLE VOLUME TO 40 -50 ¿L. RETESTING OF THE URINE SAMPLES WAS PERFORMED USING 40 ¿L AND THE CORRECT GRAM STAIN RESULTS WERE OBTAINED. THE CUSTOMER CONFIRMED THE INCORRECT STAIN RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN; THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT¿S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10995239 ↗
• MalfunctionMar 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF BAD COLORATION ISSUES WHEN TESTING STRAINS WITH THE PREVICOLOR® GRAM INSTRUMENT V2 (REF. 414292 ¿ SERIAL NUMBER: (B)(4)). THE CUSTOMER FIRST NOTICED THE ISSUE AFTER OBTAINING INCORRECT IDENTIFICATION RESULTS USING THEIR VITEK® 2 INSTRUMENT. THE CUSTOMER STATED THE INCORRECT IDENTIFICATION RESULTS WERE DUE TO INCORRECT GRAM STAIN RESULTS. THE CUSTOMER THEN PERFORMED A GRAM STAIN USING THEIR PREVICOLOR® GRAM INSTRUMENT V2 AND A GRAM NEGATIVE BIOBALL® ESCHERICHIA COLI STRAIN. THE GRAM STAIN RESULT WAS PURPLE IN COLOR INDICATIVE OF A GRAM POSITIVE RESULT. BIOMERIEUX CUSTOMER SERVICE REQUESTED INFORMATION REGARDING IMPACTED PATIENT RESULTS BUT HAS NOT RECEIVED A RESPONSE. 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. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9863020 ↗
• MalfunctionJan 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT STAINING RESULTS IN ASSOCIATION WITH THE PREVI¿ COLOR GRAM INSTRUMENT V2 (REF. 414292, SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THEIR PREVI¿ COLOR INSTRUMENT PROVIDED GRAM POSITIVE (PURPLE) STAIN RESULTS FOR BOTH GRAM POSITIVE AND GRAM NEGATIVE SAMPLES. THE CUSTOMER REPLACED THE REAGENT PACK AND BUT STILL OBTAINED DISCREPANT GRAM STAIN RESULTS. BIOMÉRIEUX CUSTOMER SERVICE DETERMINED THE PREVI¿ COLOR INSTRUMENT PERFORMED INCOMPLETE STAINING CYCLES WHICH RESULTED IN SLIDES REMAINING PURPLE (GRAM POSITIVE). AS THE CUSTOMER CONCLUDED THAT THE GRAM STAIN RESULTS COULD NOT BE USED FOR INTERPRETATION, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE NON- INTERPRETABLE RESULTS 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 9588840 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A DISCREPANT RESULT WHEN TESTING A PATIENT ISOLATE WITH THE PREVI® COLOR GRAM INSTRUMENT V2 (REF. 414292). THE CUSTOMER STATED THAT PREVI® COLOR GAVE A RESULT OF GRAM NEGATIVE COMPARED TO THE MANUAL STAINING METHOD WHICH GAVE GRAM POSITIVE RESULT. THE CUSTOMER DID NOT GIVE ANY INFORMATION REGARDING THE IDENTIFICATION OF THE STRAIN. THE CUSTOMER STATED THE GRAM NEGATIVE RESULT WAS REPORTED TO THE TREATING PHYSICIAN, BUT CONFIRMED THE DISCREPANT RESULT HAD NO ADVERSE IMPACT TO THE PATIENT¿S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9434273 ↗
• MalfunctionSep 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING INCORRECT GRAM STAIN RESULTS IN ASSOCIATION WITH PREVI COLOR GRAM INSTRUMENT (REFERENCE 414292 SERIAL (B)(4). THE CUSTOMER STATED THEY OBTAINED GRAM NEGATIVE RESULTS FOR GRAM POSITIVE ORGANISMS. SPECIFICALLY, THE CUSTOMER OBTAINED AN INCORRECT GRAM RESULT FOR A CLINICAL BLOOD CULTURE SAMPLE. 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 9131177 ↗
• MalfunctionNov 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED GRAM STAINING ISSUES FOR BLOOD CULTURE SAMPLES FROM TWO PATIENTS (P1, P2), IN ASSOCIATION WITH THE PREVI® COLOR GRAM INSTRUMENT. THE CUSTOMER STATED THAT BLOOD CULTURE BOTTLES FOR EACH PATIENT, WERE PROCESSED WITH THE BACT/ALERT ® INSTRUMENT AND FLAGGED AS POSITIVE. THE CULTURES WERE THEN PLACED ON ISOLATION MEDIA AND ALSO GRAM STAINED. THE INITIAL GRAM STAIN RESULTS WERE GRAM NEGATIVE COCCOBACILLI (P1) AND BACILLI (P2). AFTER 24 HOURS THERE WAS NO GROWTH ON THE ISOLATION MEDIA, SO THE SAME BOTTLES HAD THE GRAM STAIN REPEATED, AND THE RESULTS WERE GRAM POSITIVE COCCOBACILLI (P1) AND BACILLI (P2). VITEK® MS IDENTIFIED BOTH SAMPLES AS LISTERIA MONOCYTOGENES (GRAM POSITIVE BACILLI). THE CUSTOMER REPORTED THAT WHEN COLORING THESE BLOOD CULTURE SAMPLES IN THE INSTRUMENT, THEY WERE ACCOMPANIED BY OTHER SAMPLES IN WHICH BACTERIAL MORPHOLOGY WAS OBSERVED ADEQUATE FOR EACH TYPE OF SAMPLE AND WHERE BOTH GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA ARE DETECTED. THE CUSTOMER STATED THE WRONG RESULT WAS REPORTED TO THE PHYSICIAN BUT PATIENT TREATMENT WAS NOT IMPACTED. THE PATIENT'S CLINICAL SIGNS DID NOT COINCIDE WITH THE SYMPTOMS OF A GRAM-NEGATIVE MICROORGANISM, SO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116180 ↗
• MalfunctionNov 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED GRAM STAINING ISSUES FOR BLOOD CULTURE SAMPLES FROM TWO PATIENTS (P1, P2), IN ASSOCIATION WITH THE PREVI® COLOR GRAM INSTRUMENT. THE CUSTOMER STATED THAT BLOOD CULTURE BOTTLES FOR EACH PATIENT, WERE PROCESSED WITH THE BACT/ALERT ® INSTRUMENT AND FLAGGED AS POSITIVE. THE CULTURES WERE THEN PLACED ON ISOLATION MEDIA AND ALSO GRAM STAINED. THE INITIAL GRAM STAIN RESULTS WERE GRAM NEGATIVE COCCOBACILLI (P1) AND BACILLI (P2). AFTER 24 HOURS THERE WAS NO GROWTH ON THE ISOLATION MEDIA, SO THE SAME BOTTLES HAD THE GRAM STAIN REPEATED, AND THE RESULTS WERE GRAM POSITIVE COCCOBACILLI (P1) AND BACILLI (P2). VITEK® MS IDENTIFIED BOTH SAMPLES AS LISTERIA MONOCYTOGENES (GRAM POSITIVE BACILLI). THE CUSTOMER REPORTED THAT WHEN COLORING THESE BLOOD CULTURE SAMPLES IN THE INSTRUMENT, THEY WERE ACCOMPANIED BY OTHER SAMPLES IN WHICH BACTERIAL MORPHOLOGY WAS OBSERVED ADEQUATE FOR EACH TYPE OF SAMPLE AND WHERE BOTH GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA ARE DETECTED. THE CUSTOMER STATED THE WRONG RESULT WAS REPORTED TO THE PHYSICIAN BUT PATIENT TREATMENT WAS NOT IMPACTED. THE PATIENT'S CLINICAL SIGNS DID NOT COINCIDE WITH THE SYMPTOMS OF A GRAM-NEGATIVE MICROORGANISM, SO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116175 ↗