ARCHITECT 7K62-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380740105969), received between Sep 6, 2016 and Nov 26, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT TSH RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = TSH = 9.7737 UIU/ML; FREE T4 (FT4) = 13.64 PMOL/L; FREE T3 (FT3) = 4.24 PMOL/L. (REFERENCE RANGES: TSH: 0.35 - 4.94 UIU/ML; FT4: 9.01 - 19.05 PMOL/L; FT3: 2.63 - 5.70 PMOL/L). REPEAT AT ANOTHER LABORATORY ON (B)(6) 2025: TSH = 2.83 MIU/L; FT4 = 14.0 PMOL/L; FT3 = 4.4 PMOL/L; ANTI-TPO = <28.0 U/ML (REFERENCE RANGE USED BY THIS LAB: TSH: 0.35 - 4.55 MIU/L; FT4: 12.2 - 22.4 PMOL/L; FT3: 3.5 - 6.0 PMOL/L; ANTI-TPO: <60 U/ML. REPEATED AT A SECOND LAB: TSH = 1.5625 MIU/L; FT4 = 13.30 PMOL/L; FT3 = 3.38 PMOL/L (REFERENCE, RANGES USED BY THIS LAB: TSH: 0.35 - 4.44 MIU/L; FT4: 9.01 - 19.05 PMOL/L; FT3: 2.43 - 6.01 PMOL/L , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656271 ↗
• MalfunctionMar 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON ONE 72YRS OLD FEMALE PATIENT DIAGNOSED WITH CHRONIC CARDIAC FAILURE AND OVARIAN CANCER. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 INITIAL=18.454 UIU/ML /RECENTRIFUGED AND REPEATED=43.718 UIU/ML AND 36.559 UIU/ML; REPEATED FROM PLASMA SPECIMEN=49.303 UIU/ML; REPEATED STORED SERUM SPECIMEN ON (B)(6) 2025=22.438 UIU/ML. PREVIOUS HISTORY ON (B)(6) 2024=1.234 UIU/ML; ON (B)(6) 2024=0.012 UIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594373 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TSH RESULTS GENERATED ON THE ARCHITECT I2000 ANALYZER FOR A PATIENT THAT SHOWED CLEAR SYMPTOMS OF HYPERTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024: ARCHITECT TSH RESULT = 20.17 UIU/ML (PACKAGE INSERT NORMAL RANGE IS 0.35 UIU/ML TO 4.94 UIU/ML). DESPITE THE PATIENT¿S SYMPTOMS AND TSH VALUE, LEVOTHYROXINE WAS ADMINISTERED AT VERY HIGH DOSES (THE EXACT DOSE WAS NOT PROVIDED) AND THE PATIENT¿S SYMPTOMS CLEARLY WORSENED. THE DOCTOR NOTIFIED THE CUSTOMER THAT THERE WAS A DISCREPANCY BETWEEN THE PATIENT¿S SYMPTOMS AND THE TSH VALUE. THE CUSTOMER SENT THE SAMPLE OUT FOR A MACRO-TSH TEST TO A REFERENCE LABORATORY AND THE LAB INFORMED THE CUSTOMER THAT TESTING FOR MACRO-TSH DID NOT APPLY DUE TO THE REFERENCE LAB GENERATING A TSH RESULT OF < 0.008. AFTER 2 MONTHS, THE TREATMENT WITH LEVOTHYROXINE WAS DISCONTINUED AND THE PATIENT WAS MONITORED OVER TIME. MONITORING OF THE PATIENT¿S TSH WAS DONE BY ORTHO PLATFORM GIVING SUPPRESSED TSH RESULTS (I.E < 0.02) AND HIGH TSH VALUES WHEN GENERATED ON THE ARCHITECT AND ALINITY PLATFORMS. NO SPECIFIC VALUES FROM THESE PLATFORMS WERE PROVIDED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21568830 ↗
• MalfunctionOct 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED ARCHITECT NORMAL RANGE: 0.35 TO 4.94 UIU/ML). SID (B)(6) INITIAL RESULT = 2.8794 UIU/ML, REPEAT = 3.2094 UIU/ML, COBAS RESULT WAS >100 UIU/ML, DXL 800 RESULT WAS >48.7 UIU/ML. HETEROPHILIC BLOCKING TUBE (HBT) OF SCANTIBODIES: ARCHITECT TSH = 4.273 UIU/ML. ADDITIONAL LABORATORY DATA WAS PROVIDED: ANTI-TG: INITIAL RESULT = 44.09 IU/ML, REPEAT = 48.44 IU/ML. FREE T4; INITIAL RESULT WAS <5.15 PMOL/L, REPEAT WAS <5.15 PMOL/L. TG: INITIAL RESULT WAS <0.04 NG/ML, REPEAT WAS <0.04 NG/ML. THE PATIENT HAS A HISTORY OF A THYROID MALIGNANT TUMOR AND HAD A THYROIDECTOMY IN 2022. THE PATIENT HAS BEEN TREATED WITH RADIATION AND CHEMOTHERAPY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435330 ↗
• MalfunctionJul 1, 2023Low Test Results; Low Test Results

  ON (B)(6)2023, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON PATIENT 2. THE PATIENT RETURNED ON (B)(6)2023 AND TSH TESTING WAS PERFORMED. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2 06JUL2023 ARCHITECT TSH RESULTS (UNDILUTED) = 0.10, 0.09, 0.09, 0.10, 0.10 ¿IU/ML ARCHITECT TSH RESULTS (1:5 DILUTION) = 0.43, 0.41, 0.43, 0.43, 0.43 ¿IU/ML NEWINGTON (ALTERNATE SITE) TSH RESULT = 0.09 ¿IU/ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244183 ↗
• MalfunctionNov 11, 2022Non Reproducible Results; Non Reproducible Results

  A PHYSICIAN QUESTIONED A DIFFERENCE IN ARCHITECT THYROID STIMULATING HORMONE (TSH) RESULTS FOR A 35 YEAR OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 TSH RESULT = 0.003 MIU/ML, FREE T4 = 1.220 NG/DL, FREE T3 = 2.860 PG/ML, FERRITIN = 5.2 NG/ML. (B)(6) 2022 TSH RESULT = 3.329 MIU/ML, FREE T4 = 0.91 NG/DL, FREE T3 = 2.78 PG/ML, FERRITIN = 4.5 NG/ML. THE CUSTOMER WAS NOT ABLE TO OBTAIN CONFIRMATION REGARDING WHICH OF THE TWO RESULTS IS CORRECT. NO ADDITIONAL PATIENT INFORMATION COULD BE OBTAINED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782578 ↗
• MalfunctionNov 10, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A 9-YR OLD FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2022, SID (B)(6) = 85.94 / > 100 / X5 DILUTION = 190.03 / 197.66 UIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769333 ↗
• MalfunctionSep 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: SID 46 = 0.066 UIU/ML, X5 DILUTION = 0.2717 UIU/ML (REFERENCE RANGE: 0.35-4.94 UIU/ML). OTHER PLATFORM IS IN THE NORMAL RANGE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481770 ↗
• MalfunctionMay 13, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR 2 SAMPLES WHEN RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID(B)(6): INITIAL TSH: 2.15UIU/ML, PREVIOUS RESULT: 4.19 UIU/ML. (B)(6) 2022 SID (B)(6): INITIAL TSH: 0.46 UIU/ML, PREVIOUS RESULT: 1.09 UIU/ML.THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400449 ↗
• MalfunctionNov 9, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=3.41 UIU/ML /REPEATED=4.60 UIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778053 ↗
• MalfunctionJul 19, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TSH, ARCHITECT FREE T4 (FT4), ARCHITECT TOTAL T4 (T4), ARCHITECT TOTAL T3 (T3) RESULTS FOR A (B)(6) FEMALE PATIENT. THE FOLLOWING THYROID PROFILE DATA WAS PROVIDED (CUSTOMER EXPECTED VALUES: TSH = 0.35-4.94 UIU/ML, T4 = 4.87-11.72 UG/DL, T3 = 0.58-1.59 UG/ML, FT4 = 0.70-1.48 NG/DL): ON (B)(6) 2021, ID 11790862 = INITIAL THYROID PROFILE RESULTS: TSH = 0.93 UIU/ML, T4 = 4.07 UG/DL, T3 = 0.53 NG/ML, FT4 = 0.80 NG/DL. A NEW PATIENT SAMPLE WAS TESTED AND GAVE THE FOLLOWING RESULTS: TSH = 2.08 IU/ML, T4 = 8.54 UG/DL, T3 = 0.96 NG/DL, FT4 = NO RESULT GIVEN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191752 ↗
• MalfunctionMar 19, 2021Low Test Results; Low Test Results

  THE ACCOUNT STATED FALSE DEPRESSED ARCHITECT TSH RESULTS WERE GENERATED ON A PATIENT SAMPLE THAT TESTED HIGHER ON NON-ABBOTT METHODS. USING THE SAME PATIENT SAMPLE COLLECTED ON (B)(6) 2021, TESTING GENERATED ARCHITECT TSH OF 0.3837, 0.3829 UIU/ML, BUT NON-ABBOTT METHOD OF >5, 4.8, 4.5 UIU/ML. THE SAMPLE WAS SENT TO A DIFFERENT LABORATORY WITH ALINITY TSH OF 0.38 UIU/ML. A NEW SAMPLE COLLECTED ON (B)(6) 2021, GENERATED ARCHITECT TSH OF 0.4993, 0.4807 UIU/ML BUT NON-ABBOTT METHOD 5.08 UIU/ML AND ANOTHER LAB ALINITY TSH OF 0.38 UIU/ML. THE PATIENT IS UNDER THYROID TREATMENT UNTIL RECENTLY WITH LOW TSH VALUES AND RECEIVING STATIN TREATMENT AND FOLIC ACID SUPPLEMENTATION. THE PHYSICIANS WERE EXPECTING A TSH VALUE INCREASE. THE ENDOCRINOLOGIST CANNOT DECIDE WHICH RESULTS ARE CORRECT FOR THE PATIENT. THE ACCOUNT USES A TSH NORMAL RANGE OF 0.35 IU/ML TO 4.94 IU/ML. TESTING WITH THE ALINITY METHOD WAS PERFORMED FOR TROUBLESHOOTING AND COMPARATIVE TESTING ONLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532678 ↗
• MalfunctionOct 9, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED ARCHITECT TSH RESULTS FOR 7 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER RAN SAMPLE UNDILUTED AND 1:5 DILUTION): ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 9.5729 UIU/ML, 1:5 DILUTION = 12.2937 UIU/ML. ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 4.8958 UIU/ML, 1:5 DILUTION = 6.6525 UIU/ML. ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 3.6610 UIU/ML, 1:5 DILUTION = 5.3335 UIU/ML. ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 13.9271 UIU/ML, 1:5 DILUTION = 25.8510 UIU/ML. ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 9.3810 UIU/ML, 1:5 DILUTION = 13.3786 UIU/ML. ON (B)(6) 2020; SID: (B)(6) = UNDILUTED = 3.5024 UIU/ML, 1:5 DILUTION = 5.4958 UIU/ML. ON (B)(6) 2020; SID (B)(6) = UNDILUTED = 6.7186 UIU/ML, 1:5 DILUTION = 9.5987 UIU/ML.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10656846 ↗
• MalfunctionJan 31, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 0.13, REPEATS 0.19, 1.29 (BECKMANN), 1.0 (ROCHE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292953 ↗
• MalfunctionSep 26, 2018Low Test Results; Low Test Results

  THE CUSTOMER GENERATED A FALSELY DECREASED ARCHITECT TSH RESULT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: (B)(6) 2018: SID (B)(6), ARCHITECT TSH RESULT: 1.907 MIU/L, RETESTED USING ANOTHER ARCHITECT ANALYZER: 1.9 MIU/L THE SPECIMEN WAS TESTED USING THE SIEMENS, BECKMAN AND ROCHE METHODS AS FOLLOWS: SIEMENS: 4.689 MIU/L, ROCHE 5.11 MIU/L AND BECKMAN 5.731 AND 5.690 THE CUSTOMER INDICATED THE ARCHITECT RESULTS ALIGN WITH THE PATIENT CLINICAL STATE PER THE CUSTOMER. ON (B)(6) 2018 A NEW SPECIMEN WAS DRAN FROM THE PATIENT AND GENERATED THE FOLLOWING RESULTS: ARCHITECT TSH RESULT: 3.618 MIU/L. THE SPECIMEN WAS TESTED USING THE BECKMAN METHOD: 9.783 MIU/L. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7911343 ↗
• MalfunctionSep 5, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) WHILE USING ARCHITECT TSH REAGENTS. THE CUSTOMER USES NORMAL RANGE 0.35 TO 4.94 UIU/ML. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. SPECIMEN 1 (DRAWN 3 HOURS AFTER ADMINISTRATION OF THYRADIN); INITIAL (SID (B)(6), TESTED (B)(6) 2018) 17.01 UIU/ML; REPEAT (SID (B)(6), TESTED (B)(6) "20018") 26.71 UIU/ML. SPECIMEN 2 (DRAWN BEFORE ADMINISTRATION OF THYRADIN); INITIAL (SID (B)(6), TESTED (B)(6) 2018) 26.42 UIU/ML; REPEAT (SID (B)(6), TESTED (B)(6) 2018) 22.15 UIU/ML. THE CUSTOMER STATED THE VALUES FROM (B)(6) 2018 TESTS ARE CORRECT. THE PATIENT WAS DIAGNOSED WITH HASHIMOTO DISEASE (HYPOTHYROIDISM) AND WAS TAKING THYRADIN MEDICATION. NO CHANGE TO MEDICATION WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847234 ↗
• MalfunctionMar 21, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TSH RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 0.04 UIU/ML, REPEATS BETWEEN 0.02 AND 0.06. THE SAMPLE WAS FOUND IN THE NORMAL RANGE ON ANOTHER METHOD AT ANOTHER FACILITY: 2.8, 2.2, 2.79. THE PATIENT HAS BEEN DIAGNOSED WITH KIDNEY CANCER IN 2016. THE PATIENT HAS BEEN TAKING THE FOLLOWING MEDICATIONS, CONTINUOUSLY AROUND 3 YEARS: OMNIC OCAS 0.4 MG AND FOR AROUND 5 YEARS: PRESSAT 10 MG, MICARDIS HCT 80/25 MG, SELOZOK 50 MG. AN ULTRASOUND ON THE THYROID WAS NORMAL. THERE WAS NO NEGATIVE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359096 ↗
• MalfunctionNov 16, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULTS WHILE USING THE ARCHITECT TSH REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. SPECIMEN 1 ((B)(6)) INITIAL LESS THAN 0.1, REPEAT 0.004, 6.22. SPECIMEN 2 (NO SID PROVIDED) INITIAL 4.27, NOT REPEATED. THE PATIENT IS A NEWBORN BABY THAT WAS DIAGNOSED WITH METABOLIC AND ENDOCRINE DISORDERS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038778 ↗
• MalfunctionSep 12, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TSH RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A FEMALE PATIENT (B)(6) WITH PREVIOUS SURGICAL THYROID REMOVAL AND CURRENTLY TAKING EUTIROX AND ETATSIZIN: (B)(6), REPEAT 2.3946 MIU/L. INITIAL TSH RESULT WERE IN NORMAL RANGE. REPEATS 23.5 MIU/L, 31.8 UIU/ML (ON OTHER METHODS). A NEW SAMPLE INITIAL 2.12, REPEATED DILUTIONS 15.53, 21.17, 23.64, 24.6, 36.84 MIU/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858523 ↗
• MalfunctionMay 29, 2017Low Test Results; Low Test Results

  THE CUSTOMER GENERATED A FALSELY DECREASED ARCHITECT TSH RESULT. THE CUSTOMER PROVIDED THE FOLLOWING DATA (UIU/ML): (B)(6) 2016: INITIAL RESULT: 59.8, RETEST 11.40. ON (B)(6) 2016, THE SPECIMEN WAS RETESTED IN DUPLICATE: 59.2 AND 61.6 THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6596490 ↗
• MalfunctionMay 15, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTS THAT ONE PATIENT WHO HAS BEEN TESTED ON THE ARCHITECT PLATFORM FOR THE PAST THREE YEARS HAS TYPICALLY GENERATED LOW ARCHITECT TSH ASSAY RESULTS OF LESS THAN 0.1 MIU/ML (NORMAL REFERENCE RANGE OF 0.35 - 4.94 UIU/ML) WITH FREE T3 AND FREE T4 RESULTS WITHIN NORMAL REFERENCE RANGES. A CURRENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON A NON-ABBOTT PLATFORM WITH RESULTS FOR ALL THREE ASSAYS WITHIN THEIR NORMAL REFERENCE RANGES (NO SPECIFIC VALUES PROVIDED). THE PATIENT HAS NO KNOWN DISEASE ISSUES. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567782 ↗
• MalfunctionDec 13, 2016Low Test Results; Low Test Results

  THE CUSTOMER GENERATED FALSELY DECREASED ARCHITECT TSH RESULTS FOR 2 PATIENTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA (UIU/ML) WHICH WAS QUESTIONED BY THE PHYSICIAN (CUSTOMER PROVIDED REPORTABLE RANGE 0.02 TO 500): PATIENT 1: (B)(6) 2016: INITIAL 0.074, RETEST 1.527. PATIENT 2: (B)(6) 2016: INITIAL 0.071, RETEST 3.711. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6171590 ↗
• MalfunctionDec 5, 2016Low Test Results; Low Test Results

  THE CUSTOMER REPORTS A FALSELY DEPRESSED TSH RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FROM (B)(6) 2016: SID (B)(4) INITIAL 0.016 MIU/L, REPEAT 3.17 MIU/L. THE RESULT WAS NOT REPORTED OUT OF THE LAB AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6145602 ↗
• MalfunctionDec 4, 2016Low Test Results; Low Test Results

  THE CUSTOMER REPORTS A FALSELY DECREASED ARCHITECT TSH ASSAY RESULT ON A NEW BORN INFANT SAMPLE GENERATED ON AN ARCHITECT (B)(4) ANALYZER. A RESULT OF 0.043MIU/ML WAS GENERATED ON (B)(6) 2016 (B)(4). THERE WAS NO SAMPLE LEFT FOR RETESTING. ON (B)(6) 2016, THIS INFANT HAD GENERATED AN ARCHITECT TSH ASSAY RESULT OF 3.17 MIU/ML. ON (B)(6) 2016, A NEW SAMPLE WAS TAKEN FROM THIS PATIENT AND GENERATED A LOWER THAN EXPECTED ARCHITECT TSH ASSAY RESULT OF 0.016 MIU/L ON ARCHITECT (B)(4) ANALYZER SERIAL NUMBER (B)(4). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6144028 ↗
• MalfunctionSep 6, 2016Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED SID (B)(4): INITIAL BETWEEN 60-80, REPEAT (FALSELY DEPRESSED SID (B)(4)) 17.86, REPEATED THE NEXT DAY SID (B)(4)= 63. THERE IS NO KNOWN IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5930810 ↗