VIDAS® 99735Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 03573026140427), received between Oct 22, 2019 and Mar 11, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (22 reports).

1 FDA recall record name this device's 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, 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. Jan 4, 2018Terminated

   Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a decrease of pipetted volume.

   Z-2429-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Failure to Calibrate

  PRODUCT DESCRIPTION: THE VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. ISSUE DESCRIPTION: ON (B)(6) 2026, A CUSTOMER FROM MEXICO NOTIFIED BIOMÉRIEUX OF OBTAINING POTENTIAL FALSE RESULTS WHEN USING VIDAS ANALYZER [U] (REF. 99735U, SERIAL NUMBER: (B)(6)). THE CUSTOMER REPORTED OBTAINING QUESTIONABLE RESULTS FOR T4 AND TSH WITH VIDAS ANALYZER [U] (REF. 99735U, SERIAL NUMBER: (B)(6)). T4 GENERATED VALUES ABOVE 320, AND TSH ALSO PRESENTED IRREGULAR RESULTS; AFTER REPROCESSING, TSH PRODUCED VALUES AROUND ¿0.6. THE SAME TESTS WERE PERFORMED ON THE VIDAS KUBE, WHERE CONSISTENT AND RELIABLE RESULTS WERE OBTAINED. ADDITIONALLY, CERTAIN D DIMER MEASUREMENTS EXCEEDED 4000. TROPONIN RESULTS WERE 2.5 ON THE FIRST MEASUREMENT AND 3.7 ON THE SECOND FOR A PATIENT DIAGNOSED WITH MYOCARDIAL INFARCTION. THE VIDAS REPORTS AND THE NUMBER OF IMPACTED SAMPLE WERE NOT PROVIDED. THE CUSTOMER INDICATED THAT PREVENTIVE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568515 ↗
• MalfunctionMay 26, 2022High Test Results; High Test Results

  ON (B)(6) 2022, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF A FAILED QCV TEST ON POSITION A1 ON VIDAS ANALYZER (REF. 99735, SERIAL NUMBER : (B)(4) PERFORMED WITH QCV-QUALITY CONTROL VIDAS 60T (REF. 30706, BATCH NUMBER: 1009015680, EXPIRY DATE : 07/10/2022) RESULTING IN AN OVERESTIMATED RESULT OF VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1008544030). CUSTOMER FACED A QCV ALERT ON (B)(6) 2022, ON POSITION A1. THE TV1 VALUE HAD TO BE GREATER THAN OR EQUAL TO 5.5. IN THIS CASE, THE CUSTOMER OBTAINED DURING THE FIRST RUN : TV1 = 1.06 AND THE SECOND RUN : TV1 = 1.06. FOLLOWING THESE RESULTS, THE SECTION HAS BEEN DISABLED UNTIL A FSE WAS DISPATCHED ON CUSTOMER SITE. THE FSE MADE THE REPAIR. THE PUMP PRESSURE WAS VERIFIED AND THE PRESSURE IN A1 WAS LOW. THE FSE CLEANED THE CHANNELS IN SECTION A AND CHANGED THE SEALS. THE PUMP PRESSURE IS NOW GOOD. FOLLOWING THIS ISSUE, THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS OF THE RESULTS OBTAINED IN THE SECTION A1 SINCE LAST CONFORM QCV PERFORMED ON (B)(6) 2022. AFTER THE RETROSPECTIVE ANALYSIS, THE CUSTOMER IDENTIFIED ONE OVERESTIMATED RESULT OBTAINED WITH VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01, BATCH NUMBER: 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517585 ↗
• MalfunctionNov 21, 2021False Negative Result; False Negative Result

  DESCRIPTION OF THE ISSUE: ON (B)(6) 2021, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT FOLLOWING A POTENTIAL QCV FAILURE WHILE TESTING A PATIENT SAMPLE WITH THEIR VIDAS® ANALYSER (REFERENCE (B)(4), SN (B)(4)); THE QCV-QUALITY CONTROL VIDAS 60T IS REFERENCE # (B)(4). THE CUSTOMER REPORTED INTERMITTENT QCV FAILURES. QCV FIRST FAILED IN A1 POSITION WITH RESULT OF TV1= 0.64 AND R3 = 352 RFU. (RANGE: TV1 > 5.4 AND R3 >= 4100 RFU). CUSTOMER RAN QCV TWO MORE TIMES WITH PASSING RESULTS. THE RESULTS OBTAINED WAS: TV1 = 7.39 AND 7.32 AND R3 VALUES OF 7297 AND 7081. HOWEVER, ON (B)(6) 2021, THE CUSTOMER RAN A VARICELLA TEST IN POSITION A1 AND GOT A RESULT OF 0.22 WHICH IS NEGATIVE. CUSTOMER DID NOT REPORT THE TEST SINCE THE RESULT DID NOT MAKE SENSE FOR THE PATIENT. SHE RERAN THE SAMPLE IN D1 AND GOT A RESULT OF 2.19 WHICH IS POSITIVE. THIS POSITIVE RESULT MATCHED THE PATIENTS CLINICAL HISTORY. THE LAST GOOD QCV WAS DONE ON (B)(6) 2021. A RETROSPECTIVE ANALYSIS WAS DONE FROM THE LAST GOOD QCV (ON (B)(6) 2021), THERE WAS NO DIFFERENCE OF RESULTS AND NO CHANGE OF INTERPRETATION FOR ANY PATIENT EXCEPT FOR THE PREVIOUSLY NOTED VARICELLA (VZV) TEST. ON (B)(6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850113 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON 27-SEP-2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON 27-SEP-2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73. THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON 08-SEP-2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707671 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4. FIRST RUN : A1 =1.18. D1 = 0.37. SECOND RUN: A1 =1.2. D1 =5.73. THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707594 ↗
• MalfunctionOct 27, 2021Low Test Results; Low Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73 THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707592 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73 . THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707577 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON 27-SEP-2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON 27-SEP-2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73 THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707551 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73 THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707537 ↗
• MalfunctionOct 27, 2021High Test Results; High Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73. THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707534 ↗
• MalfunctionOct 27, 2021Low Test Results; Low Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN: A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73. THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707474 ↗
• MalfunctionOct 27, 2021Low Test Results; Low Test Results

  INTENDED USE: VIDAS ANALYZER SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). QUALITY CONTROL VIDAS® (QCV) (REF 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS AND MINI VIDAS INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM THE UNITED STATES REPORTED QCV FAILURE WHEN USING VIDAS ANALYSER ¿ REF. 99735. THE FIRST QCV FAILED ON (B)(6) 2021 WITH A1 AND D1 TV1 VALUE TOO LOW. SECOND RUN A1 FAILED LOW AND D1 WAS LOW BUT PASSED. LIMIT VALUE =5.4 FIRST RUN : A1 =1.18 D1 = 0.37 SECOND RUN A1 =1.2 D1 =5.73 THE QCV FAILURE WAS CONFIRMED ON A1 AND THE CUSTOMER HAD TO PERFORM A THIRD QCV ON D1. THE LAST QCV PASSED ON (B)(6) 2021. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. VERIFIED NO CHANGE IN VALUE FOR AFFECTED SECTIONS A1 AND D1, BUT POSSIBLE CLOG. THE FSE USED A PUMP CLEANING TOOL FOR ALL SECTIONS, VERIFIED DEBRIS WERE CLEARED OUT FROM A1 AND D1. PERFORMED SECOND PUMP TEST AND VERIFIED VALUES WERE SHOWING NORMAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707465 ↗
• MalfunctionJun 3, 2021False Positive Result; False Positive Result

  PRODUCT DESCRIPTION: THE VIDAS¿ SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE VIDAS¿ SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS¿ ASSAY KITS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM (B)(6) REPORTED QCV FAILURE THAT LEAD TO (B)(6) RESULTS DURING PATIENT SAMPLE TESTING WITH VIDAS (B)(6) AND HBS KITS. INDEED, TWO (B)(6) RESULTS IN (B)(6) AND ONE IN (B)(6) WERE FOUND IN THE PERIOD FROM (B)(6) 2021 WHICH WAS THE PERIOD BETWEEN THE LAST VALID QCV AND THE FIRST INVALID QCV. THE NUMBER OF PATIENTS IMPACTED BY THE DISCREPANT RESULTS WAS NOT SPECIFIED. THE CUSTOMER SPECIFIED THAT THE POSITIVE RESULTS ARE NEVER GIVEN TO THE PATIENT WITHOUT BEING CONFIRMED BY ANOTHER TECHNIQUE. THE CUSTOMER STATED THAT NO OTHER INVALID RESULTS WERE OBTAINED OR DELAYED RESULTS THAT WOULD COMPROMISE PATIENTS. A BIOMRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930124 ↗
• MalfunctionDec 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV FAILURE OCCURRING IN POSITION B1 WHEN USING THE VIDAS® ANALYSER INSTRUMENT (REF. 99735, SERIAL (B)(4) ). THE RETROSPECTIVE ANALYSIS PERFORMED SHOWED AN IMPACT ON VIDAS® B·R·A·H·M·S PCT¿ (PROCALCITONIN) TEST RESULTS. THIS QCV FAILURE OCCURRED ON (B)(6) 2020. FSE INTERVENTION WAS PERFORMED ON (B)(6) 2020, AND THE ISSUE WAS RESOLVED BY A SEAL REPLACEMENT. THE LAST CONFORMING QCV WAS PERFORMED ON (B)(6) 2020. QCV FAILURE IS NOT A MALFUNCTION; HOWEVER, IT CAN BE ASSOCIATED WITH INCORRECT RESULTS (PRIOR TO QCV FAILURE). THEREFORE, BIOMÉRIEUX REQUESTS CUSTOMERS TO CONDUCT A RETROSPECTIVE ANALYSIS FROM THE LAST PASSED QCV UNTIL THE PRESENT QCV FAILURE. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS FOR SAMPLES RUN IN POSITION B1 OF THE VIDAS ANALYSER FROM THE (B)(6). DURING THE CONCERNED PERIOD OF TIME, FOR VIDAS PCT, 72 SAMPLES WERE RUN IN POSITION B1. IT WAS INDICATED THAT ONLY 26 OF THESE SAMPLES WERE RERAN IN RETROSPECTIVE ANALYSIS (OTHER SAMPLES WERE NOT AVAILABLE). FOR THESE 26 SAMPLES, THE RETROSPECTIVE REVIEW DETERMINED THAT THREE (3) SAMPLES HAD INITIAL UNDERESTIMATED RESULTS REGARDLESS OF THE RANGE OF EXPECTED VALUES F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11097754 ↗
• MalfunctionDec 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV FAILURE OCCURRING IN POSITION B1 WHEN USING THE VIDAS® ANALYSER INSTRUMENT (REF. 99735, SERIAL (B)(4)). THE RETROSPECTIVE ANALYSIS PERFORMED SHOWED AN IMPACT ON VIDAS® B·R·A·H·M·S PCT¿ (PROCALCITONIN) TEST RESULTS. THIS QCV FAILURE OCCURRED ON (B)(6) 2020. FSE INTERVENTION WAS PERFORMED ON (B)(6) 2020, AND THE ISSUE WAS RESOLVED BY A SEAL REPLACEMENT. THE LAST CONFORMING QCV WAS PERFORMED ON (B)(6) 2020. QCV FAILURE IS NOT A MALFUNCTION; HOWEVER, IT CAN BE ASSOCIATED WITH INCORRECT RESULTS (PRIOR TO QCV FAILURE). THEREFORE, BIOMÉRIEUX REQUESTS CUSTOMERS TO CONDUCT A RETROSPECTIVE ANALYSIS FROM THE LAST PASSED QCV UNTIL THE PRESENT QCV FAILURE. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS FOR SAMPLES RUN IN POSITION B1 OF THE VIDAS ANALYSER FROM THE (B)(6). DURING THE CONCERNED PERIOD OF TIME, FOR VIDAS PCT, 72 SAMPLES WERE RUN IN POSITION B1. IT WAS INDICATED THAT ONLY 26 OF THESE SAMPLES WERE RERAN IN RETROSPECTIVE ANALYSIS (OTHER SAMPLES WERE NOT AVAILABLE). FOR THESE 26 SAMPLES, THE RETROSPECTIVE REVIEW DETERMINED THAT THREE (3) SAMPLES HAD INITIAL UNDERESTIMATED RESULTS REGARDLESS OF THE RANGE OF EXPECTED VALUES FO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11097726 ↗
• MalfunctionDec 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A QCV FAILURE OCCURRING IN POSITION B1 WHEN USING THE VIDAS® ANALYSER INSTRUMENT (REF. 99735, SERIAL (B)(4). THE RETROSPECTIVE ANALYSIS PERFORMED SHOWED AN IMPACT ON VIDAS® B·R·A·H·M·S PCT¿ (PROCALCITONIN) TEST RESULTS. THIS QCV FAILURE OCCURRED ON (B)(6) 2020. FSE INTERVENTION WAS PERFORMED ON (B)(6) 2020, AND THE ISSUE WAS RESOLVED BY A SEAL REPLACEMENT. THE LAST CONFORMING QCV WAS PERFORMED ON (B)(4) 2020. QCV FAILURE IS NOT A MALFUNCTION. HOWEVER, IT CAN BE ASSOCIATED WITH INCORRECT RESULTS (PRIOR TO QCV FAILURE). THEREFORE, BIOMÉRIEUX REQUESTS CUSTOMERS TO CONDUCT A RETROSPECTIVE ANALYSIS FROM THE LAST PASSED QCV UNTIL THE PRESENT QCV FAILURE. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS FOR SAMPLES RUN IN POSITION B1 OF THE VIDAS ANALYSER FROM THE (B)(6). DURING THE CONCERNED PERIOD OF TIME, FOR VIDAS PCT, 72 SAMPLES WERE RUN IN POSITION B1. IT WAS INDICATED THAT ONLY 26 OF THESE SAMPLES WERE RERAN IN RETROSPECTIVE ANALYSIS (OTHER SAMPLES WERE NOT AVAILABLE). FOR THESE 26 SAMPLES, THE RETROSPECTIVE REVIEW DETERMINED THAT THREE (3) SAMPLES HAD INITIAL UNDERESTIMATED RESULTS REGARDLESS OF THE RANGE OF EXPECTED VALUES FOR THE DI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11097685 ↗
• MalfunctionJul 1, 2020Output Problem; Output Problem

  A CUSTOMER IN FINLAND NOTIFIED BIOMÉRIEUX OF AN INSTANCE WHERE THE CUSTOMER'S VIDAS® ANALYZER (REF 99735, SERIAL (B)(4)) STOPPED RUNNING WHILE PROCESSING EXTERNAL QUALITY CONTROL SAMPLES. THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED ONE (1) TIME AND ALL SEGMENTS OF THE INSTRUMENT WERE AFFECTED. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES. THE CUSTOMER CONFIRMED THAT THERE WERE NO PATIENT SAMPLES BEING PROCESSED AT THIS TIME, BUT RESULTS FOR THE EXTERNAL QUALITY CONTROL SAMPLES WERE DELAYED DUE TO HAVING TO PREPARE NEW STRIPS AND RE-RUN TESTS. THE FOLLOWING TESTS WERE BEING PERFORMED WHEN THE VIDAS® ANALYZER STOPPED RUNNING: REF. (B)(4) VIDAS® HIV DUO ULTRA (3 SAMPLES) REF. (B)(4) VIDAS® HBC IGM II (3 SAMPLES), REF. (B)(4) VIDAS® HBS AG ULTRA (3 SAMPLES), REF. (B)(4) VIDAS® ANTI-HBC TOTAL II (3 SAMPLES). THE CUSTOMER RESTARTED THE INSTRUMENT AND THIS CORRECTED THE ISSUE. A PRELIMINARY INVESTIGATION PERFORMED BY GLOBAL CUSTOMER SERVICE (GCS) IDENTIFIED THAT THERE WERE MULTIPLE INSTANCES OF THE INSTRUMENT RESETTING WHILE THE TESTS WERE BEING PERFORMED, HOWEVER THE CAUSE FOR THE RESETS HAS NOT BEEN IDENTIFIED AT THIS TIME. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10220850 ↗
• InjuryJun 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV DETECTED FAILURE WHICH OCCURRED AT SECTION A1 OF THEIR VIDAS® ANALYSER (REF. 99735, SERIAL (B)(4)). THE CUSTOMER CONFIRMED THE MOST RECENT PASSING QCV TEST OCCURRED ON (B)(6) 2020 AND PERFORMED A RETROSPECTIVE ANALYSIS FOR THE IMPACTED TIMEFRAME. THE RETROSPECTIVE ANALYSIS IDENTIFIED ONE (1) PROCALCITONIN (PCT) SAMPLE WAS INITIALLY UNDERESTIMATED. THE ORIGINAL TEST RESULT OBTAINED WAS <0.05 NG/ML, THE REPEAT TEST OBTAINED A VALUE OF > 2 NG/ML. THE CUSTOMER STATED THE UNDERESTIMATED RESULT WAS REPORTED TO THE PHYSICIAN, AND TREATMENT WAS WITHHELD BASED UPON THE UNDERESTIMATED RESULT OF <0.05 NG/ML. TREATMENT OF THE PATIENT WAS ADJUSTED AFTER OBTAINING THE CORRECTED VALUE OF > 2 NG/ML. ALTHOUGH THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY DIRECT NEGATIVE IMPACT TO THE PATIENT'S STATE OF HEALTH, THE CUSTOMER CONFIRMED TREATMENT OF THE PATIENT WAS DELAYED BASED UPON THE ERRONEOUS UNDERESTIMATED PCT RESULT. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: Misdiagnosis

  MAUDE report 10105030 ↗
• MalfunctionMay 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON THE (B)(6) 2019, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV DETECTED FAILURE AT POSITION E1 OF THE VIDAS® ANALYZER (REF. 99735, SERIAL (B)(4)). THE CUSTOMER CONFIRMED THE LAST SUCCESSFUL QCV TEST OCCURRED ON (B)(6) 2019; A RETROSPECTIVE ANALYSIS WAS PERFORMED FOR THE IMPACTED TIME FRAME. THE RETROSPECTIVE ANALYSIS IDENTIFIED NINE (9) PROCALCITONIN (PCT) TESTS WERE PERFORMED AT SECTION E1 USING VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450). OF THE NINE (9) IMPACTED SAMPLES, ONE SAMPLE (SAMPLE 4), WAS INITIALLY UNDERESTIMATED OBTAINING A VALUE OF 45.82, WITH REPEAT RESULTS OF >200 AND 175. THE INITIAL RESULT OF 45.82 WAS REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THE CUSTOMER CONFIRMED THE VALUE OF 45.82 HAS THE SAME INTERPRETATION AS THE RETEST VALUES OF >200 AND 175. ALL OTHER REPEATED SAMPLES OBTAINED RESULTS IN AGREEMENT WITH THE INITIAL RESULTS, OR WITH INSIGNIFICANT DIFFERENCE AS COMPARED TO THE INITIAL RESULTS. NOTE: THE UNITS OF MEASURE WERE NOT REPORTED. FOR SAMPLE 4, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10102174 ↗
• MalfunctionMay 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6)-2020, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV DETECTED FAILURE AT POSITON B1 IN ASSOCIATION WITH THE VIDAS® ANALYZER (REF. 99735, SERIAL (B)(4)). THE CUSTOMER STATED THE MOST RECENT PASSING QCV TEST WAS COMPLETED ON (B)(6) 2020. A RETROSPECTIVE ANALYSIS WAS PERFORMED FOR THE IMPACTED TIME FRAME. TEN (10) PROCALCITONIN (PCT) SAMPLES FROM SEPARATE PATIENTS WERE TESTED IN POSITON B1 BETWEEN (B)(6) 2020 AND(B)(6) 2020. SEVEN (7) SAMPLES WERE REPEATED, THREE (3) SAMPLES WERE NOT REPEATED. ONE (1) SAMPLE WAS INITIALLY UNDERESTIMATED FOR PCT. 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. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THE PUMP AT POSITION B1 WAS CLOGGED. THE FSE PERFORMED A PUMP CLEANER THEN PERFORMED A LEAK TEST AND QCV TEST; BOTH TESTS PASSED. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10020177 ↗
• MalfunctionApr 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A QCV DETECTED FAILURE OCCURRING AT SECTION A1 OF THE VIDAS® ANALYZER (REF.99735, SERIAL NUMBER (B)(4)). THE CUSTOMER CONFIRMED THE LAST PASSING QCV TEST WAS PERFORMED ON (B)(6) 2020. A RETROSPECTIVE ANALYSIS WAS PERFORMED FOR THE IMPACTED TIMEFRAME. THE RETROSPECTIVE ANALYSIS IDENTIFIED THIRTY-FIVE (35) PROCALCITONIN AND D-DIMER SAMPLES WERE TESTED AT POSITION A1 DURING THE IMPACTED TIMEFRAME. EIGHT (8) SAMPLES WERE UNABLE REPEATED. ALL OTHER SAMPLES FROM THE IMPACTED TIME PERIOD WERE RETESTED. THE FOLLOWING THREE RESULTED IN AN INTERPRETATION CHANGE. SAMPLE 1 D-DIMER ORIGINAL RESULT = 280.94 NG/ML - NEGATIVE, SAMPLE 1 D-DIMER REPEAT RESULT = 726 NG/ML ¿ POSITIVE. SAMPLE 2 PCT ORIGINAL RESULT = 0.11 NG/ML, SAMPLE 2 PCT REPEAT RESULT = 0.53 NG/ML. SAMPLE 3 PCT ORIGINAL RESULT = <0.05 NG/ML, SAMPLE 3 PCT REPEAT RESULT = 0.75 NG/ML. THE CUSTOMER CONFIRMED THE INITIAL RESULTS WERE REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910654 ↗
• MalfunctionApr 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A QCV DETECTED FAILURE OCCURRING AT SECTION A1 OF THE VIDAS® ANALYZER (REF.99735, SERIAL NUMBER (B)(4)). THE CUSTOMER CONFIRMED THE LAST PASSING QCV TEST WAS PERFORMED ON (B)(4) 2020. A RETROSPECTIVE ANALYSIS WAS PERFORMED FOR THE IMPACTED TIMEFRAME. THE RETROSPECTIVE ANALYSIS IDENTIFIED THIRTY-FIVE (35) PROCALCITONIN AND D-DIMER SAMPLES WERE TESTED AT POSITION A1 DURING THE IMPACTED TIMEFRAME. EIGHT (8) SAMPLES WERE UNABLE REPEATED. ALL OTHER SAMPLES FROM THE IMPACTED TIME PERIOD WERE RETESTED. THE FOLLOWING THREE RESULTED IN AN INTERPRETATION CHANGE. SAMPLE 1 D-DIMER ORIGINAL RESULT = 280.94 NG/ML - NEGATIVE, SAMPLE 1 D-DIMER REPEAT RESULT = 726 NG/ML ¿ POSITIVE. SAMPLE 2 PCT ORIGINAL RESULT = 0.11 NG/ML, SAMPLE 2 PCT REPEAT RESULT = 0.53 NG/ML. SAMPLE 3 PCT ORIGINAL RESULT = <0.05 NG/ML, SAMPLE 3 PCT REPEAT RESULT = 0.75 NG/ML. THE CUSTOMER CONFIRMED THE INITIAL RESULTS WERE REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910627 ↗
• MalfunctionApr 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV (B)(4) FAILURE OCCURRING AT SECTION A1 OF THE VIDAS® ANALYZER (REF.99735, SERIAL NUMBER (B)(4)). THE CUSTOMER CONFIRMED THE LAST PASSING QCV TEST WAS PERFORMED ON 01-MAR-2020. A RETROSPECTIVE ANALYSIS WAS PERFORMED FOR THE IMPACTED TIMEFRAME. THE RETROSPECTIVE ANALYSIS IDENTIFIED THIRTY-FIVE (35) PROCALCITONIN AND D-DIMER SAMPLES WERE TESTED AT POSITION A1 DURING THE IMPACTED TIMEFRAME. EIGHT (8) SAMPLES WERE UNABLE REPEATED. ALL OTHER SAMPLES FROM THE IMPACTED TIME PERIOD WERE RETESTED. THE FOLLOWING THREE RESULTED IN AN INTERPRETATION CHANGE. SAMPLE 1 D-DIMER ORIGINAL RESULT = 280.94 NG/ML - NEGATIVE, SAMPLE 1 D-DIMER REPEAT RESULT = 726 NG/ML ¿ POSITIVE. SAMPLE 2 PCT ORIGINAL RESULT = 0.11 NG/ML, SAMPLE 2 PCT REPEAT RESULT = 0.53 NG/ML. SAMPLE 3 PCT ORIGINAL RESULT = <0.05 NG/ML, SAMPLE 3 PCT REPEAT RESULT = 0.75 NG/ML. THE CUSTOMER CONFIRMED THE INITIAL RESULTS WERE REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SIT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910591 ↗
• MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV-DETECTED FAILURE AT SECTION A1 IN ASSOCIATION WITH THE VIDAS® ANALYSER (REF. 99735, SERIAL NUMBER (B)(4)) . THE CUSTOMER CONFIRMED THE QCV DETECTED FAILURE OCCURRED ON (B)(6) 2020 AND THE LAST SUCCESSFUL QCV WAS PERFORMED ON (B)(6) 2020; A RETROSPECTIVE ANALYSIS WAS COMPLETED FOR THE IMPACTED TIMEFRAME. THE RETROSPECTIVE ANALYSIS SHOWED A TOTAL OF FOURTEEN (14) VIDAS PCT ASSAYS WERE PERFORMED AT POSITION A1 BETWEEN 20-FEB-2020 AND 26-FEB-2020. THE CUSTOMER CONFIRMED ELEVEN (11) SAMPLES SHOWED NO INTERPRETATION CHANGE. THE RETROSPECTIVE ANALYSIS ALSO FOUND ONE (1) SAMPLE WAS INITIALLY UNDERESTIMATED FOR PCT. NO RETEST DATA WAS PROVIDED FOR TWO (2) IMPACTED SAMPLES. THE CUSTOMER 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 9883214 ↗
• MalfunctionJan 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A QCV-DETECTED FAILURE OF THE VIDAS® ANALYZER (REFERENCE (B)(4), SERIAL(B)(4)). THE QCV DETECTED FAILURE OCCURRED ON (B)(6) 2019 THE MOST RECENT SUCCESSFUL QCV OCCURRED ON (B)(6) 2019. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS FOLLOWING A QCV DETECTED FAILURE ON POSITION A1 FOR THE AFFECTED TIMEFRAME. THE CUSTOMER STATED A TOTAL OF FORTY-SEVEN (47) PATIENTS SAMPLES WERE TESTED AT POSITION A1 DURING THE AFFECTED TIMEFRAME, SIX (6) PATIENTS SAMPLES WERE FOUND TO BE UNDERESTIMATED FOR PROCALCITONIN (PCT). RESULTS FOR SAMPLE A ARE LISTED BELOW: SAMPLE A: PCT REPORTED VALUE < 0.1 NG/ML ; PCT REPEAT VALUE = 5.9 NG/ML. THE CUSTOMER REPORTED THAT THESE RESULTS (ORIGINAL AND CORRECTED RESULTS) HAVE BEEN REPORTED TO THE PHYSICIAN. 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 FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER AND CONFIRMED THE PUMP AT POSITION A1 WAS CLOGGED. THE FSE CLEANED THE PUMP AND REPLACED THE SEALS. THE FSE THEN PERFORMED A QCV AND LEAK TEST, ALL RESULTS PASSED. A BIOMÉRIEUX INTERNAL INVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9582764 ↗