VITROS 1726926Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10758750000012), received between May 11, 2023 and Sep 25, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “High Test Results” (26 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026High Test Results; Non Reproducible Results

  An Ortho Field Application Specialist (FAS) on behalf of a customer, contacted the Ortho Clinical Diagnostics (Ortho) Global Technical Solutions Center (TSC) to report a non-reproducible, higher than expected VITROS AMON result was obtained from a single patient sample processed using VITROS Chemistry Products AMON Slides Lot 1022-0269-7519 on a VITROS XT 3400 Chemistry System. Patient sample VITROS AMON result of 261.1 umol/L versus an expected result of 114.7 umol/L Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The non-reproducible, higher than expected VITROS AMON result was not reported out of the laboratory. There have been no allegations of patient harm as a result of this event. This report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number (b)(4) and Reportability Assessment 615879.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899006 ↗
• MalfunctionApr 14, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE AND MULTIPLE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A STANDARD SOURCE BIO QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT: 1020-0267-1181 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 214.0 UMOL/L VERSUS AN EXPECTED RESULT OF 48.0 UMOL/L STANDARD SOURCE BIO CONTROL LEVEL 1 (LOT UNKNOWN) VITROS AMON RESULTS OF 207.0, 210.0, 207.0 AND 203.0 UMOL/L VS AN EXPECTED RESULT OF 167.667 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877946 ↗
• MalfunctionApr 14, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE AND MULTIPLE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A STANDARD SOURCE BIO QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-1181 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 214.0 UMOL/L VERSUS AN EXPECTED RESULT OF 48.0 UMOL/L STANDARD SOURCE BIO CONTROL LEVEL 1 (LOT UNKNOWN) VITROS AMON RESULTS OF 207.0, 210.0, 207.0 AND 203.0 UMOL/L VS AN EXPECTED RESULT OF 167.667 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877940 ↗
• MalfunctionApr 14, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE AND MULTIPLE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A STANDARD SOURCE BIO QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-1181 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 214.0 UMOL/L VERSUS AN EXPECTED RESULT OF 48.0 UMOL/L STANDARD SOURCE BIO CONTROL LEVEL 1 (LOT UNKNOWN) VITROS AMON RESULTS OF 207.0, 210.0, 207.0 AND 203.0 UMOL/L VS AN EXPECTED RESULT OF 167.667 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877936 ↗
• MalfunctionApr 14, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE AND MULTIPLE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A STANDARD SOURCE BIO QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-1181 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 214.0 UMOL/L VERSUS AN EXPECTED RESULT OF 48.0 UMOL/L STANDARD SOURCE BIO CONTROL LEVEL 1 (LOT UNKNOWN) VITROS AMON RESULTS OF 207.0, 210.0, 207.0 AND 203.0 UMOL/L VS AN EXPECTED RESULT OF 167.667 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877925 ↗
• MalfunctionApr 14, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE AND MULTIPLE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A STANDARD SOURCE BIO QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-1181 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 214.0 UMOL/L VERSUS AN EXPECTED RESULT OF 48.0 UMOL/L STANDARD SOURCE BIO CONTROL LEVEL 1 (LOT UNKNOWN) VITROS AMON RESULTS OF 207.0, 210.0, 207.0 AND 203.0 UMOL/L VS AN EXPECTED RESULT OF 167.667 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877919 ↗
• MalfunctionMar 11, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED RESULT FROM A SINGLE VITROS LIQUID PERFORMANCE VERIFIER (LPV) FLUID USING VITROS AMMONIA (AMON) SLIDE LOT: 1020-0267-3666 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV II, LOT: M2779 VITROS AMON RESULT OF 150 UMOL/L VS. THE EXPECTED RESULT OF 199.7 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS AMON RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575536 ↗
• MalfunctionFeb 5, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS MAS ALCOHOL/AMMONIA CONTROLS, LOT: A/A2609, TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS AMON SLIDE LOT: 1022-0269-7571 WAS THE AFFECTED SLIDE LOT NUMBER. MAS LEVEL 2 AMON RESULT OF 175.4 UMOL/L VS. THE VITROS LAB LINK PEER MEAN OF 145.45 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE NON-VITROS MAS CONTROL IS A NON-PATIENT SAMPLE. THE CUSTOMER PROVIDED NO EXAMPLES OF ERRONEOUS VITROS AMON PATIENT SAMPLE RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272708 ↗
• MalfunctionFeb 5, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1022-0269-7570 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 98.5 UMOL/L VERSUS AN EXPECTED RESULT OF 17.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN. THE PATIENT WAS SENT TO A SISTER SITE TO BE REDRAWN AND RETESTED. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE INITIAL VITROS RESULT. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266990 ↗
• MalfunctionJan 15, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT: 1020-0268-5902 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO A REPEAT RESULT FROM THE SAME SAMPLE OBTAINED ON THE SITES VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 111.2 UMOL/L VERSUS AN EXPECTED RESULT OF 24.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24084720 ↗
• MalfunctionDec 22, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-3614 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO A REPEAT RESULT FROM THE SAME SAMPLE OBTAINED ON THE SITES VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 153.0 UMOL/L VERSUS AN EXPECTED RESULT OF 8.1 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS AMON RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865072 ↗
• MalfunctionDec 15, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-3614 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT RESULT OF 141.3 UMOL/L VERSUS THE EXPECTED RESULT OF 23.1 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS AMON RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804158 ↗
• MalfunctionAug 7, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J1) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J2) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N (B)(6) (J2) VITROS AMON SLIDE LOT 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT 1020-0267-3613 CAP SAMPLE CHM-10 VITROS AMON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741911 ↗
• MalfunctionAug 7, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS: 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS: 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N: (B)(6) (J1) VITROS LI SLIDE LOT: 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N: (B)(6) (J2) VITROS LI SLIDE LOT: 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT: 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N: (B)(6) (J2) VITROS AMON SLIDE LOT: 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT: 1020-0267-3613 CAP SAMPLE CHM-10 V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737556 ↗
• MalfunctionNov 6, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROL, LOT: 54420, USING VITROS AMMONIA (AMON) SLIDE LOT: 1019-0266-4652 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 AMON RESULTS OF 111.3? MOL/L VERSUS THE EXPECTED RESULT OF 91.2? MOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER DID NOT PROCESS ANY PATIENT SAMPLES WHILE THE QUALITY CONTROL RESULTS WERE OUTSIDE EXPECTATION, AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619586 ↗
• MalfunctionOct 22, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT 54390, USING VITROS AMMONIA (AMON) SLIDE LOTS 1019-0266-5803 AND SLIDE LOT 1020-0265-0764 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS AMON REAGENT SLIDE LOT 1020-0265-0764: BIORAD LEVEL 2 AMON RESULTS OF 61.71, 63.51, 112.45, 68.28, 70.84, 68.46, AND 62.67 ?MOL/L VS. THE EXPECTED RESULT OF 92.88 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 187.76 ?MOL/L VS. THE EXPECTED RESULT OF 239.90 ?MOL/L VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 122.83, 113.59, 72.81, AND 59.75 ?MOL/L VS. THE EXPECTED RESULT OF 92.40 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 184.23 ?MOL/L VS. THE EXPECTED RESULT OF 242.10 ?MOL/L LIQUID PERFORMANCE VERIFIER II AMON RESULTS OF 129.17, 142.36, 143.74, 145.21, 145.97, 148.40, 149.81, 150.95, 152.00, 152.40, 153.53 AND 154.35 ?MOL/L VS. THE EXPECTED RESULT OF 194.70 ?MOL/L AFTER SERVICE INTERVENTIONS USING VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 115.40, 115.04, AND 112.20 ?MOL/L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509800 ↗
• MalfunctionJan 3, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A PATIENT SAMPLE USING A NEW VITROS AMON SLIDE LOT TESTED ON A XT7600 INTEGRATED SYSTEM WHEN COMPARED TO A VITROS AMON RESULT OBTAINED FROM THE SAME SAMPLE USING THE PREVIOUS VITROS AMON SLIDE LOT TESTED ON THE SAME VITROS 5600 INTEGRATED SYSTEM. CORRELATION SAMPLE 2 VITROS AMON RESULT OF (B)(4) VS. THE EXPECTED RESULT OF (B)(4). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS AMON RESULT OBTAINED FROM THE CORRELATION SAMPLE WAS NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438781 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM (S/N (B)(6) ) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM (S/N (B)(6) ) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220899 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220880 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM (S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM (S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220870 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM (S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM (S/N (B)(6) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220860 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM (S/N (B)(6)) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM (S/N (B)(6)) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220858 ↗
• MalfunctionNov 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE (B)(6) CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN PROCESSING MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24011 ON A VITROS 5600 AND VITROS XT7600 SYSTEM. VITROS 5600 SYSTEM (S/N (B)(6)) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULTS 238.1, 239.2, 231.7, 213.7 AND 210.1 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L VITROS XT7600 SYSTEM (S/N (B)((6)) MAS ALCOHOL/AMMONIA CONTROL LEVEL 2, LOT AA24012 VITROS AMON RESULT 209.5 UMOL/L VERSUS BASELINE MEAN 167.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 603952.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220851 ↗
• MalfunctionAug 11, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE RECOVERED FROM THE CALIBRATOR LEVEL 2 FROM CALIBRATOR KIT LOT 0522, TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS AMON CALIBRATOR LEVEL 2 RESULTS OF 39 AND 32 UMOL/L VS. THE EXPECTED RESULT OF 102 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510490 ↗
• MalfunctionAug 11, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE RECOVERED FROM THE CALIBRATOR LEVEL 2 FROM CALIBRATOR KIT LOT 0522, TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS AMON CALIBRATOR LEVEL 2 RESULTS OF 39 AND 32 UMOL/L VS. THE EXPECTED RESULT OF 102 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 602732.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510429 ↗