Dimension® QuikLYTE® Multisensor Na+/K+/Cl- 10445058Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00842768014291), received between Jul 2, 2019 and Apr 29, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (29 reports).

7 other recalls cover devices cleared under the same FDA submission (K112999); they may or may not involve this specific model.

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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED SODIUM (NA+) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA+) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034357 ↗
• MalfunctionApr 22, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIANS AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIANS IN AMENDED REPORTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953292 ↗
• MalfunctionMar 20, 2026Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES AFTER STANDARD A REPLACEMENT ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL SYSTEM. THE REPROCESSED RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS AND CORRELATED WITH THE PATIENT'S HISTORY. THE REPROCESSED RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646766 ↗
• MalfunctionJan 30, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT. THE REPEAT RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219872 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF A DEPRESSED SODIUM (NA) RESULTS WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 5FD811. AN INITIAL DEPRESSED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLES. THE INITIAL DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS THEN RETESTED ON AN ALTERNATE DIMENSION EXL SYSTEM AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. 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 23731933 ↗
• MalfunctionApr 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED ON BOTH SYSTEMS, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS DRAWN AND TESTED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928578 ↗
• MalfunctionFeb 25, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT OBTAINED WAS CRITICALLY LOW AND THE SAME SAMPLE WAS AUTO REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE AUTO REPROCESSED RESULT RECOVERED LOW AND WAS CONSIDERED ERRONEOUS. THE AUTO REPROCESSED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM ON THE NEXT DAY AND A HIGHER RESULT WAS OBTAINED. THE HIGHER REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. ON THE EVENT DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE SAME REDRAWN SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM ON THE NEXT DAY AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456947 ↗
• MalfunctionFeb 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE INITIAL DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL 200 SYSTEM AND OBTAINED HIGHER RESULTS. THE HIGHER RESULTS MATCHED THE CLINICAL PICTURE OF THE PATIENTS, CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED NA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445653 ↗
• MalfunctionFeb 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE INITIAL DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL 200 SYSTEM AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT MATCHED THE CLINICAL PICTURE OF THE PATIENT, CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445632 ↗
• MalfunctionDec 10, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. HIGHER REPROCESSED RESULTS CONSISTENT WITH THE PATIENT¿S HISTORY WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894544 ↗
• MalfunctionNov 13, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON THREE (3) PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE HIGHER REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672495 ↗
• MalfunctionOct 3, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED SODIUM RESULT WAS REPORTED TO THE PHYSICIAN(S) AND AS A RESULT, IT WAS INDICATED THE PATIENT WAS HOSPITALIZED DUE TO A "CONCERN REGARDING OVER-CORRECTION DUE TO A >6 MMOL/L DELTA CHECK" AND "RISK FOR DEMYELINATION" AND WAS TREATED. THE PATIENT WAS ADMINISTERED 1 LITER OF NORMAL SALINE AND STARTED DDAVP-D5W. THREE (3) SUBSEQUENT SAMPLE DRAWS FROM THE SAME PATIENT WERE PERFORMED AND PROCESSED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. HIGHER SODIUM RESULTS WERE OBTAINED FOR ALL THREE SAMPLES, WHICH WERE CONSIDERED CORRECT AND REPORTED. AN ADDITIONAL SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER SODIUM RESULT WAS OBTAINED AND CONSIDERED CORRECT. THE ORIGINAL SAMPLE THAT OBTAINED AN ERRONEOUS SODIUM RESULT, WAS RETESTED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM THE FOLLOWING DAY AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED AS THE AMENDED RESULT. THERE ARE NO KNO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358673 ↗
• MalfunctionSep 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WITH A QUIKLYTE INTEGRATED MULTISENSOR (IMT) ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED AS AN AMENDED RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20324565 ↗
• MalfunctionJul 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON THREE (3) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL WITH LM SYSTEM. THE REPROCESSED RESULTS RECOVERED HIGHER AND WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836666 ↗
• MalfunctionJul 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED SODIUM (NA) PATIENT SAMPLE RESULT ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS AUTO REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND A LOWER RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND A LOWER RESULT WAS REPRODUCED. THE AUTO-REPROCESSED RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654609 ↗
• MalfunctionMay 8, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT ON A DIMENSION EXL WITH LM SYSTEM . THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM AND A LOWER RESULT WAS OBTAINED AND CONSIDERED ERRONEOUS. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE NOT QUESTIONED. THE SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL 200 SYSTEM AND THE RESULT OBTAINED WAS HIGHER, MATCHED PATIENT HISTORY AND WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271446 ↗
• MalfunctionMay 6, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS FOR TWO (2) PATIENT SAMPLES ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. FOR SAMPLE (B)(6) THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND THE ERRONEOUS RESULT WAS REPRODUCED. THEN THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. FOR SAMPLE (B)(6) THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED IN DUPLICATE ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE REPROCESSED RESULTS WERE LOWER THAN THE INITIAL RESULT AND CONSIDERED ERRONEOUS. THE INITIAL RESULT OBTAINED ON AN ALTERNATE DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM MATCHED THE PATIENT¿S HISTORY, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247129 ↗
• MalfunctionMay 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULTS ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. IT IS UNKNOWN IF THE SAME SAMPLES OR NEW SAMPLES DRAWN FROM THE SAME PATIENTS WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM AND ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. THE REPROCESSED AND/OR REDRAWN RESULTS OBTAINED WERE HIGHER, MATCHED PATIENT HISTORY AND WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219879 ↗
• MalfunctionApr 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. HIGHER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179603 ↗
• MalfunctionApr 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TEN (10) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. HIGHER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179599 ↗
• MalfunctionApr 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED SODIUM (NA) PATIENT RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. A LOWER RESULT OBTAINED, MATCHED PATIENT'S HISTORY AND WAS CONSIDERED CORRECT AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED SODIUM (NA) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089368 ↗
• MalfunctionApr 2, 2024High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE LOWER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020746 ↗
• MalfunctionMar 27, 2024Low Test Results; Low Test Results

  THREE (3) FALSELY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED 16-MARCH-2024 ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987149 ↗
• MalfunctionMar 1, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822722 ↗
• MalfunctionMar 1, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE PROCESSED ON A DIMENSION EXL SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL SYSTEM AND ON AN ALTERNATE DIMENSION EXL SYSTEM. THE REPROCESSED RESULTS WERE HIGHER COMPARED TO THE INITIAL RESULT AND WERE CONSIDERED CORRECT. THE HIGHER REPROCESSED RESULT FROM THE ORIGINAL SYSTEM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112999. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2019 · Sep 28, 2018 · Terminated
  Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension EXL 200 00630414593579; Dimension EXL with LM 00630414593500; Dimension EXL with
• Z-1651-2018 · Jun 29, 2017 · Terminated
  Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
• Z-0461-2016 · Nov 10, 2015 · Terminated
  Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The
• Z-0460-2016 · Nov 10, 2015 · Terminated
  Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The R
• Z-1615-2015 · Apr 2, 2015 · Terminated
  Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimen
• Z-2133-2014 · May 27, 2014 · Terminated
  Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
• Z-2182-2012 · Jul 17, 2012 · Terminated
  Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microproc