Dimension® Flex® reagent cartridge TAC 10700795Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00842768035425), received between Mar 22, 2018 and Sep 29, 2026 — classified as 121 malfunctions.

The most frequently reported specific device problem is “High Test Results” (69 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. May 7, 2026Class IIOpen, Classified

   A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

   Z-2398-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 30, 2023Class IIOpen, Classified

   Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).

   Z-1258-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results; Low Test Results

  The customer reported that erroneous Tacrolimus (TAC) results were obtained on two patient samples on a Dimension EXL 200 Integrated Chemistry System. The initial results were reported to the physician(s) and questioned. The samples were repeated on the original system. The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous TAC results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931827 ↗
• MalfunctionJun 12, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED FOR TACROLIMUS (TAC) ON THE SAME SYSTEM TWO ADDITIONAL TIMES: BOTH TIMES RECOVERING HIGHER THAN THE INITIAL RESULT. ONE OF THE HIGHER RESULTS WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491122 ↗
• MalfunctionJun 11, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467731 ↗
• MalfunctionMay 28, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM THREE ADDITIONAL TIMES: ONCE USING A 1:2 DILUTION, USING NO DILUTION, AND USING ANOTHER 1:2 DILUTION. LOWER RESULTS WERE OBTAINED. THE RESULT OBTAINED USING THE SECOND 1:2 DILUTION WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323499 ↗
• MalfunctionApr 30, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS A DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM WHEN COMPARED TO THE INITIAL RESULT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER REPROCESSED THE SAME PATIENT SAMPLE ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE THIRD TEST OBTAINED A RESULT SIMILAR TO THE INITIAL, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046298 ↗
• MalfunctionApr 8, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS PROCESSED THREE TIMES ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT AND THE 2ND REPEAT RESULT WERE CONSISTENT, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THE 1ST REPEAT RESULT WAS ELEVATED AND CONSIDERED ERRONEOUS. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813980 ↗
• MalfunctionMar 23, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED TWICE ON THE ORIGINAL INSTRUMENT. THE FIRST REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED ERRONEOUS. THE SECOND REPEAT RESULT RECOVERED SIMILAR TO THE INITIAL RESULT. THE INITIAL AND THE SECOND REPEAT RESULTS WERE CONSIDERED CORRECT AND THE RESULT OF 10.4 NG/ML WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668041 ↗
• MalfunctionMar 6, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531496 ↗
• MalfunctionMar 2, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON ONE (1) PATIENT SAMPLE WAS OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM TWICE. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND ONE OF THE RESULTS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482051 ↗
• MalfunctionMar 2, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULTS ON TWO (2) PATIENT SAMPLES WERE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM TWICE. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND ONE OF THE RESULTS WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481790 ↗
• MalfunctionMar 26, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS ON SIX (6) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE SENT TO AN ALTERNATE FACILITY AND REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULTS OBTAINED FROM AN ALTERNATE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695773 ↗
• MalfunctionMar 26, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS ON THIRTEEN (13) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE SENT TO AN ALTERNATE FACILITY AND REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULTS OBTAINED FROM AN ALTERNATE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695772 ↗
• MalfunctionSep 19, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUS ELEVATED TACROLIMUS (TAC) PATIENT RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. A DIFFERENT SAMPLE WAS PROCESSED ON AN ALTERNATE METHOD 1 (NON-SIEMENS METHOD). THE ALTERNATE METHOD 1 (NON-SIEMENS METHOD) RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE LOWER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THE CUSTOMER REPEATED THE SAMPLE WITH DILUTION ON THE DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND ALTERNATE METHOD 1 AND ANOTHER ALTERNATE METHOD 2 (NON-SIEMENS METHOD) FOR COMPARISON. THE PATIENT HAD A HEART TRANSPLANT. THE TACROLIMUS MEDICATION WAS DELAYED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY OR ERRONEOUS ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260283 ↗
• MalfunctionJul 3, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667123 ↗
• MalfunctionJun 21, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. NO RESULT WAS OBTAINED ON THE FIRST RUN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM AND ELEVATED RESULT WAS OBTAINED. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM WITH 1:3 MANUAL DILUTION AND WITHOUT DILUTION. THE REPROCESSED RESULTS RECOVERED LOWER, WERE CONSISTENT AND CONSIDERED CORRECT. THE REPROCESSED RESULT OF 10.99 NG/ML WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585551 ↗
• MalfunctionMay 16, 2024High Test Results; High Test Results

  A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY ELEVATED PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER LOOKED BACK INTO THE RECORDS AND FOUND ON (B)(6) 2024 THE PATIENT HAD A LOWER TACROLIMUS (TAC) RESULT. ON (B)(6) 2024 THE SAME SAMPLE WAS TESTED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND DID NOT PRODUCE A RESULT BUT GENERATED AN ABNORMAL REACTION MESSAGE. THE REDRAWN SAMPLE FROM (B)(6) 2024 WAS SENT OUT TO A REFERENCE LAB USING LIQUID CHROMATOGRAPHY MASS SPECTROMETRY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PATIENT SAMPLE RESULT WITH TACROLIMUS (TAC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332495 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AND REPORTED TO THE PHYSICIAN A FALSELY ELEVATED TACROLIMUS (TAC) RESULT FOR ONE PATIENT SAMPLE ON (B)(6) 2023. INITIALLY THE CUSTOMER OBSERVED A SYSTEM ERROR (ABNORMAL REACTION FLAG) FOR THE NEAT TAC RESULT. THE SAMPLE WAS THEN DILUTED, A TAC RESULT WITHOUT AN ERROR MESSAGE WAS OBTAINED AND REPORTED. THE CUSTOMER SENT THE PATIENT SAMPLE TO BE TESTED AT ANOTHER FACILITY ON AN ALTERNATE METHODOLOGY. THE TAC RESULT FROM THE ALTERNATE METHODOLOGY WAS LOWER. THE CUSTOMER PROCEEDED TO TEST SUBSEQUENT TAC SAMPLES FOR THIS PATIENT ON ALTERNATE METHODOLOGY AND REPORT THE PATIENT RESULTS FROM THE ALTERNATE METHODOLOGY TO THE PHYSICIAN BEGINNING (B)(6) 2023. FOR THIS ONE PATIENT SAMPLE, THE SIEMENS TESTING AFTER (B)(6) 2023 WAS FOR INVESTIGATION PURPOSES ONLY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM. SIEMENS HEALTHINEERS HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION FROM THE CUSTOMER FOR ACCURACY AND COMPLETENESS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19139749 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AND REPORTED TO THE PHYSICIAN A FALSELY ELEVATED TACROLIMUS (TAC) RESULT FOR ONE PATIENT SAMPLE ON (B)(6) 2023. INITIALLY THE CUSTOMER OBSERVED A SYSTEM ERROR (ABNORMAL REACTION FLAG) FOR THE NEAT TAC RESULT. THE SAMPLE WAS THEN DILUTED, A TAC RESULT WITHOUT AN ERROR MESSAGE WAS OBTAINED AND REPORTED. THE CUSTOMER SENT THE PATIENT SAMPLE TO BE TESTED AT ANOTHER FACILITY ON AN ALTERNATE METHODOLOGY. THE TAC RESULT FROM THE ALTERNATE METHODOLOGY WAS LOWER. THE CUSTOMER PROCEEDED TO TEST SUBSEQUENT TAC SAMPLES FOR THIS PATIENT ON ALTERNATE METHODOLOGY AND REPORT THE PATIENT RESULTS FROM THE ALTERNATE METHODOLOGY TO THE PHYSICIAN BEGINNING (B)(6) 2023. FOR THIS ONE PATIENT SAMPLE, THE SIEMENS TESTING AFTER (B)96) 2023 WAS FOR INVESTIGATION PURPOSES ONLY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM. SIEMENS HEALTHINEERS HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION FROM THE CUSTOMER FOR ACCURACY AND COMPLETENESS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19139718 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AND REPORTED TO THE PHYSICIAN A FALSELY ELEVATED TACROLIMUS (TAC) RESULT FOR ONE PATIENT SAMPLE ON (B)(6) 2023. INITIALLY THE CUSTOMER OBSERVED A SYSTEM ERROR (ABNORMAL REACTION FLAG) FOR THE NEAT TAC RESULT. THE SAMPLE WAS THEN DILUTED, A TAC RESULT WITHOUT AN ERROR MESSAGE WAS OBTAINED AND REPORTED. THE CUSTOMER SENT THE PATIENT SAMPLE TO BE TESTED AT ANOTHER FACILITY ON AN ALTERNATE METHODOLOGY. THE TAC RESULT FROM THE ALTERNATE METHODOLOGY WAS LOWER. THE CUSTOMER PROCEEDED TO TEST SUBSEQUENT TAC SAMPLES FOR THIS PATIENT ON ALTERNATE METHODOLOGY AND REPORT THE PATIENT RESULTS FROM THE ALTERNATE METHODOLOGY TO THE PHYSICIAN BEGINNING (B)(6) 2023. FOR THIS ONE PATIENT SAMPLE, THE SIEMENS TESTING AFTER (B)(6) 2023 WAS FOR INVESTIGATION PURPOSES ONLY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM. SIEMENS HEALTHINEERS HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION FROM THE CUSTOMER FOR ACCURACY AND COMPLETENESS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19139703 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AND REPORTED TO THE PHYSICIAN A FALSELY ELEVATED TACROLIMUS (TAC) RESULT FOR ONE PATIENT SAMPLE ON (B)(6) 2023. INITIALLY THE CUSTOMER OBSERVED A SYSTEM ERROR (ABNORMAL REACTION FLAG) FOR THE NEAT TAC RESULT. THE SAMPLE WAS THEN DILUTED, A TAC RESULT WITHOUT AN ERROR MESSAGE WAS OBTAINED AND REPORTED. THE CUSTOMER SENT THE PATIENT SAMPLE TO BE TESTED AT ANOTHER FACILITY ON AN ALTERNATE METHODOLOGY. THE TAC RESULT FROM THE ALTERNATE METHODOLOGY WAS LOWER. THE CUSTOMER PROCEEDED TO TEST SUBSEQUENT TAC SAMPLES FOR THIS PATIENT ON ALTERNATE METHODOLOGY AND REPORT THE PATIENT RESULTS FROM THE ALTERNATE METHODOLOGY TO THE PHYSICIAN BEGINNING (B)(6) 2023. FOR THIS ONE PATIENT SAMPLE, THE SIEMENS TESTING AFTER (B)(6) 2023 WAS FOR INVESTIGATION PURPOSES ONLY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM. SIEMENS HEALTHINEERS HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION FROM THE CUSTOMER FOR ACCURACY AND COMPLETENESS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19139667 ↗
• MalfunctionApr 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AND REPORTED TO THE PHYSICIAN A FALSELY ELEVATED TACROLIMUS (TAC) RESULT FOR ONE PATIENT SAMPLE ON (B)(6) 2023. INITIALLY THE CUSTOMER OBSERVED A SYSTEM ERROR (ABNORMAL REACTION FLAG) FOR THE NEAT TAC RESULT. THE SAMPLE WAS THEN DILUTED, A TAC RESULT WITHOUT AN ERROR MESSAGE WAS OBTAINED AND REPORTED. THE CUSTOMER SENT THE PATIENT SAMPLE TO BE TESTED AT ANOTHER FACILITY ON AN ALTERNATE METHODOLOGY. THE TAC RESULT FROM THE ALTERNATE METHODOLOGY WAS LOWER. THE CUSTOMER PROCEEDED TO TEST SUBSEQUENT SAMPLES FOR THIS PATIENT ON ALTERNATE METHODOLOGY AND REPORT THE PATIENT RESULTS TO THE PHYSICIAN BEGINNING (B)(6) 2023. FOR THIS ONE PATIENT SAMPLE, THE SIEMENS TESTING AFTER (B)(6) 2023 WAS FOR INVESTIGATION PURPOSES ONLY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM. SIEMENS HEALTHINEERS HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION FROM THE CUSTOMER FOR ACCURACY AND COMPLETENESS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19139611 ↗
• MalfunctionFeb 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT TACROLIMUS (TAC) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729962 ↗
• MalfunctionFeb 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. THE PHYSICIAN CHANGED THE TACROLIMUS (TAC) DOSE. AFTER CHANGING THE DOSE, THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN IN A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719743 ↗
• MalfunctionFeb 16, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). IN A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719741 ↗
• MalfunctionJan 8, 2024High Test Results; High Test Results

  FIVE (5) DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULTS WERE OBTAINED ON A DIMENSION® EXL¿ 200 SYSTEM. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL INSTRUMENT. LOWER RESULTS OBTAINED WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465807 ↗