ARCHITECT 2P24-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 646 adverse event reports that list this exact device (DI 00380740003753), received between Sep 16, 2016 and Sep 30, 2026 — classified as 1 death, 8 injuries, 637 malfunctions.

The most frequently reported specific device problem is “High Test Results” (305 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0682-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 646 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Test Results

  The customer observed a falsely decreased Calcium result generated on the ARCHITECT c4000 Processing Module for one sample. The following results were provided:(Customer provided Calcium reference range: 8.1-10.0 mg/dL).SID (b)(6), 74-year-old female patient:Calcium result = 5.8 mmol/L, repeat result = 9.2 mg/dL. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947903 ↗
• MalfunctionSep 14, 2026Thermal Decomposition of Device

  The customer observed error 3598 when processing on the ARCHITECT c4000 Processing Module. Further troubleshooting was performed and found cpu11 to cnn5 cable have burnt mark. There was no impact to patient management or user safety.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753451 ↗
• MalfunctionMay 15, 2026Leak/Splash

  THE FIELD SERVICE REPRESENTATIVE (FSR) WAS TROUBLESHOOTING A LEAK INSIDE THE ARCHITECT C4000 PROCESSING MODULE. DURING THIS ACTIVITY, LIQUID SPLASHED FROM THE EXTERNAL WASTE PUMP WHILE THE FSR WAS RESEATING THE CONNECTOR BETWEEN THE TUBING AND THE EXTERNAL WASTE PUMP. THE LIQUID SPLASH CONTACTED THE FSR¿S FACE, HANDS, EYEGLASSES, AND CLOTHING. AT THE TIME OF THE INCIDENT, THE FSR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING EYEGLASSES, A LAB COAT, AND GLOVES. THERE WAS NO MEDICAL TREATMENT WAS REQUIRED OR PROVIDED BY A PHYSICIAN. THERE WAS NO IMPACT TO THE OPERATOR, AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183943 ↗
• MalfunctionApr 1, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FROM ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6): 59 YRS OLD FEMALE: INITIAL=7.5 MG/DL /REPEATED=1.5MG/DL. ON (B)(6) 2026 SID (B)(6): 80 YRS OLD MALE: INITIAL=6.9 MG/DL /REPEATED=1.8 MG/DL. CUSTOMER REFERENCE RANGE FOR MAGNESIUM=1.6 TO 2.6 MG/DL; CRITICAL RANGE=< 1.0 OR > 5.0 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755285 ↗
• MalfunctionMar 25, 2026Imprecise or Erratic Results

  THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, FOR SID (B)(6), THE INITIAL MAGNESIUM RESULT WAS 6.58 MG/DL (PATIENT PANEL), THE SAMPLE WAS REPEATED WITH OTHER SAMPLES RUNNING AND THE RESULT WAS 1.31 MG/DL. THE SAMPLE WAS REPEATED WITH NO OTHER SAMPLES RUNNING AND THE RESULT WAS 1.91 MG/DL (REPORTED). ON (B)(6) 2026, FOR SID (B)(6), THE INITIAL MAGNESIUM RESULT WAS 0.94 MG/DL (PATIENT PANEL), THE SAMPLE WAS REPEATED WITH OTHER SAMPLES RUNNING AND THE RESULT WAS 4.25 MG/DL. THE SAMPLE WAS REPEATED WITH NO OTHER SAMPLES RUNNING AND THE RESULT WAS 3.97 MG/DL (REPORTED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691201 ↗
• MalfunctionMar 19, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CALCIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 2 MG/DL, REPEATED NORMAL (THE VALUE WAS NOT PROVIDED). EXPECTED VALUES: 9.0 - 10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640033 ↗
• MalfunctionMar 19, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR A 25-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 1.6 - 2.6 MG/DL): SID (B)(6) 2026 RESULTED 8.0 REPEATED 1.8, 1.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637410 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL POTASSIUM RESULT= 7.923 MMOL/L; REPEAT RESULT= 4.767 MMOL/L. SID (B)(6), INITIAL POTASSIUM RESULT= 7.977 MMOL/L; REPEAT RESULT= 4.561 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547531 ↗
• MalfunctionFeb 20, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM2 RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGES AT DIFFERENT FACILITIES - ARCHITECT 2.25¿2.55 MMOL/L, ALINITY 2.1¿2.55 MMOL/L): (B)(6) 2026 SAMPLE ID (B)(6), (86-YEAR-OLD FEMALE) INITIAL RESULT = 4.47 MMOL/L, (B)(6) 2026 SAME SAMPLE WAS REPEATED ON ALINITY ANALYZER AT ANOTHER LABORATORY AND RESULT = 2.35 MMOL/L. (B)(6) 2026 SAMPLE ID (B)(6), (77-YEAR-OLD FEMALE) INITIAL RESULT = 5.18 MMOL/L, REPEAT RESULT = 5.26 MMOL/L. (B)(6) 2026 NEW SAMPLE OBTAINED AND RESULT ON THE RADIOMETER = 1.16 MMOL/L. (B)(6) 2026 SAME SAMPLE WAS REPEATED ON ALINITY ANALYZER AT ANOTHER LABORATORY AND RESULT = 2.36 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402603 ↗
• MalfunctionFeb 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER FOR 2 PATIENTS. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. INITIAL RESULT = 0.4 MMOL/L, REPEAT RESULTS = 0.8 MMOL/L. THE CUSTOMER USES REFERENCE RANGE: 0.74-1.07 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293118 ↗
• MalfunctionFeb 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT PATIENT RESULTS FOR MULTIPLE ASSAYS FOR 2 PATIENTS WHEN PROCESSED ON THE ARCHITECT ANALYZER. RESULTS WERE NOT REPORTED TO MEDIAL PROVIDER. THE FOLLOWING DATA PROVIDED. SID (B)(6). CALCIUM, INITIAL RESULT = 4.6 MG/DL, REPEAT RESULT = 9.1 MG/DL, REFERENCE RANGE= 8.5 ¿ 10.5 MG/DL. CO2, INITIAL RESULT = 5 MMOL/L, REPEAT RESULT = 23 MMOL/L, REFERENCE RANGE= 20 ¿ 31 MMOL/L GLUCOSE, INITIAL RESULT = 20 MG/DL, REPEAT RESULT = 101 MG/DL, REFERENCE RANGE= 70 ¿ 100 MG/DL. SODIUM, INITIAL RESULT = 110 MMOL/L, REPEAT RESULT = 140 MMOL/L, REFERENCE RANGE= 135 ¿ 145 MMOL/L. SID (B)(6) CALCIUM, INITIAL RESULT = 5.8 MG/DL, REPEAT RESULT = 9.2 MG/DL, REFERENCE RANGE= 8.5 ¿ 10.5 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245738 ↗
• MalfunctionJan 23, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER FOR 2 PATIENTS. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. INITIAL RESULT = 0.4 MMOL/L, REPEAT RESULTS = 0.8 MMOL/L THE CUSTOMER USES REFERENCE RANGE: 0.74-1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160614 ↗
• MalfunctionJan 22, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED POTASSIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR A 62-YEAR-OLD FEMALE TAKING A POTENT NEUROLEPTIC MEDICATION. THE PATIENT SAMPLE WAS REPEATED ON THE BLOOD GAS ANALYZER WITH A HIGHER RESULT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 3.4 - 5.1 MMOL/L): SID (B)(6), INITIAL POTASSIUM RESULT= 1.5 MMOL/L, WHICH WAS CONFIRMED BY A SECOND BLOOD DRAW; THE SAMPLE WAS TEST AT ANOTHER FACILITY WITH THE SAME RESULTS; REPEAT RESULTS ON THE BLOOD GAS ANALYSIS (CAPILLARY BLOOD DRAW)= 4 MMOL/L. THE PATIENT WAS RETESTED ON (B)(6) 2026 WITH A RESULT OF 2.5 MMOL/L. THE PATIENT RECEIVED IV POTASSIUM. THE CUSTOMER CONFIRMED THE IV POTASSIUM THE PATIENT RECEIVED WASN'T CONSIDERED UNNECESSARY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153891 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR A 79-YEAR-OLD MALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.6 - 2.6 MG/DL): SID (B)(6), INITIAL MAGNESIUM RESULT= 6.6 MG/DL; REPEAT RESULT= 2.1 MG/DL . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960246 ↗
• MalfunctionDec 29, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED NORMAL RANGE: 3.5 TO 5.1 MMOL/L): (B)(6) 2025, SID (B)(6): INITIAL RESULT = 6.65 MMOL/L, REPEAT = 4.83 MMOL/L, (B)(6) 2025, SID (B)(6): INITIAL RESULT = 6.88 MMOL/L, REPEAT = 5.03 MMOL/L, (B)(6) 2025, SID (B)(6): INITIAL RESULT = 6.68 MMOL/L, REPEAT = 4.94 MMOL/L , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907296 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED POTASSIUM RESULTS GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE SAMPLES WERE REPEATED, AND NORMAL LOWER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED ONE EXAMPLE: CUSTOMER¿S NORMAL RANGE: 3.5 TO 5.1 MMOL/L. INITIAL POTASSIUM RESULT = 7.8 MMOL/L, REPEAT RESULT = 3.0 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882128 ↗
• MalfunctionDec 22, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED THE ARCHITECT C4000 PRINTOUT SHOWED THE INCORRECT PATIENT DEMOGRAPHICS, WHEN COMPARED WITH INFORMATION ON BARCODE LABEL FOR A SAMPLE. THE BARCODE LABEL CONTAINS THE CORRECT PATIENT DEMOGRAPHICS. PATIENT 1: SID (B)(6) RUN (B)(6) 2025 WITH PATIENT ID (B)(6) INITIALS (B)(6) FOR IRON TEST. THIS PATIENT WAS HOSPITALIZED A MONTH AGO AND HAS NOT BEEN BACK FOR ANYTHING SINCE. PATIENT 2: CORRECT PATIENT ID (B)(6) WITH PATIENT INITIALS LL WHICH ALSO HAD AN IRON TEST CUSTOMER MANUALLY ORDERED TEST FOR CORRECT PATIENT ID (B)(6) AND REPORTED THE RESULTS WITH CORRECT DEMOGRAPHICS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873054 ↗
• MalfunctionDec 19, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.6 - 2.6 MG/DL): (B)(6) 2025, SID (B)(6), INITIAL MAGNESIUM RESULT= 2.40 MG/DL; (B)(6) 2025, REPEAT RESULT= 6.93 MG/DL. THE PATIENT IS A 34-YEAR-OLD FEMALE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849099 ↗
• MalfunctionDec 17, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR ONE 53-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (MMOL/L): (B)(6) INITIAL RESULT 2.86 MMOL/L, REPEATED 0.87 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826872 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON AN ARCHITECT C4000 ANALYZER FOR ONE PATIENT. SID (B)(6) INITIAL RESULT = 5.98 MG/DL, REPEAT RESULTS = 1.98 MG/DL AND 1.90 MG/DL (NORMAL RANGE 1.6-2.5 MG/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757271 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM (MG) RESULT GENERATED ON THE ARCHITECT C4000 FOR A 72-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.6-2.6 MG/DL): (B)(6) 2025 SAMPLE ID (B)(6), INITIAL RESULT = 7.23 MG/DL, REPEAT RESULT = 1.91 MG/DL, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 1.82 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660463 ↗
• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED RESULTS ON MULTIPLE ASSAYS GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE SAMPLES WERE REPEATED, AND NORMAL RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: SODIUM: 136 TO 145 MMOL/L. POTASSIUM: 3.5 TO 5.1 MMOL/L. CALCIUM: 8.4 TO 10.2 MG/DL. TOTAL BILIRUBIN: 0.2 TO 1.2 MG/DL. (B)(6) 2025 SID (B)(6): INITIAL SODIUM RESULT = 106 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2025 SID (B)(6): INITIAL POTASSIUM RESULT = 2.2 MMOL/L, REPEAT RESULT = 4.1 MMOL/L. INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT RESULT = 138 MMOL/L. (B)(6) 2025 SID (B)(6): INITIAL SODIUM RESULT = 112 MMOL/L, REPEAT RESULT = 141 MMOL/L. INITIAL TOTAL BILIRUBIN RESULT = < 0.1 MG/DL, REPEAT RESULT = 0.4 MG/DL. (B)(6) 2025 SID (B)(6): INITIAL CALCIUM RESULT = 5.7 MG/DL, REPEAT RESULT = 9.2 MG/DL. (B)(6) 2025 SID (B)(6): INITIAL POTASSIUM RESULT = 2.2 MMOL/L, REPEAT RESULT = 3.9 MMOL/L. INITIAL SODIUM RESULT = 120 MMOL/L, REPEAT RESULT = 138 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633924 ↗
• MalfunctionNov 20, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM AND CHLORIDE RESULTS GENERATED ON A PATIENT WHEN PROCESSED ON THE ARCHITECT C4000 ANALYZER. RESULTS WERE REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2025, INITIAL SODIUM RESULTS=160 MMOL/L, REPEAT RESULTS FROM ANOTHER ANALYZER = 142 MMOL/L. ON (B)(6) 2025, INITIAL CHLORIDE RESULTS= 134 MMOL/L, REPEAT RESULTS FROM THIS ANALYZER AND ANOTHER ANALYZER WERE 109 MMOL/L. THE CUSTOMER USES REFERENCE RANGE FOR SODIUM (135-145 MMOL/L) & CHLORIDE (98-110 MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609020 ↗
• MalfunctionNov 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: CUSTOMER¿S REFERENCE RANGE 1.6-2.6 MG/DL. (B)(6) 2025, SID (B)(6), 72-YEAR-OLD FEMALE, INITIAL MAGNESIUM RESULT= 4.95 MG/DL; REPEAT RESULT= 1.09 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512005 ↗
• MalfunctionNov 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR A 39-YEAR-OLD MALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 137-147 MMOL/L): SID (B)(6), INITIAL SODIUM RESULT= 103 MMOL/L; REPEAT RESULT (AUTOMATIC)= 111 MMOL/L; REPEAT RESULT ON SAME SAMPLE, SAMPLE INSTRUMENT= 138 MMOL/L; REPEAT RESULT ON ANOTHER INSTRUMENT (C402434)= 137 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478605 ↗