Elecsys TSH 08443432190Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 07613336157633), received between Jul 8, 2021 and Sep 28, 2026 — classified as 2 injuries, 114 malfunctions.

The most frequently reported specific device problem is “High Test Results” (93 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917890 ↗
• MalfunctionMar 25, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH V2, ELECSYS CORTISOL II, AND ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: TSH = 0.0171 MIU/L CORTISOL = < 1.50 NMOL/L WITH A DATA FLAG FT4 = < 0.500 PMOL/L WITH A DATA FLAG. THE SAMPLE REPEATED WITH THE FOLLOWING VALUES ON (B)(6) 2026: TSH = 3.23 MIU/L CORTISOL = 527 NMOL/L FT4 = 16.3 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689364 ↗
• InjuryJan 28, 2026High Test Results

  ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS TSH V2 ON A COBAS 8000 E 801 MODULES. THE PATIENT WAS ALLEGEDLY TREATED WITH LEVOTHYROXINE AFTER MEASUREMENTS WERE PERFORMED WITH THE FIRST SAMPLE AND THE DOSAGE WAS ALLEGEDLY INCREASED AFTER MEASUREMENTS WERE PERFORMED WITH THE SECOND SAMPLE. THE FIRST SAMPLE REPORTEDLY RESULTED IN A TSH VALUE OF 3.74 MU/L WHEN TESTED WITH THE ROCHE METHOD ON THE FIRST E 801 ANALYZER. THE SAME SAMPLE WAS TESTED USING THE SIEMENS METHOD AND THE TSH RESULT WAS REPORTED TO BE 0.01 MU/L. THE SAMPLE WAS TESTED WITH THE ROCHE METHOD AFTER POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE TSH RECOVERY WAS REPORTEDLY 1 %. THE SAMPLE WAS ALSO TESTED WITH THE ROCHE METHOD AFTER TREATMENT IN A HETEROPHILIC ANTIBODY BLOCKING TUBE AND IT WAS REPORTED THAT THERE WAS NO INDICATION OF HETEROPHILIC ANTIBODIES. AFTER THE FIRST SAMPLE MEASUREMENT, THE PATIENT WAS ASSUMED TO HAVE HYPOTHYROIDISM AND WAS REPORTEDLY TREATED WITH LEVOTHYROXINE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS TREATED WITH LEVOTHYROXINE BASED ON THE TSH VALUE OBTAINED WITH THE ROCHE METHOD. ON (B)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201278 ↗
• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 4 PATIENT SAMPLES FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 4 YEARS, 3-ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1-FEMALE, 1-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183971 ↗
• MalfunctionOct 23, 2025High Test Results; Output Problem; High Test Results; Output Problem

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PURE E 402 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369438 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 3 PATIENTS TESTED ON COBAS E801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 58 YEARS, ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 2-MALE, 1-ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586692 ↗
• MalfunctionApr 29, 2025High Test Results; Chemical Problem; High Test Results; Chemical Problem

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925125 ↗
• MalfunctionJan 30, 2025Non Reproducible Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TSH ON A COBAS E 402 ANALYTICAL UNIT AND FOR 1 PATIENT ON A COBAS E411 DISK SYSTEM. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275034 ↗
• MalfunctionApr 29, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS TSH RESULTS FOR 2 PATIENT SAMPLES. 2. PATIENT AGE RANGE: 1 PATIENT: 86 YEARS, OTHER: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 1 F, 1 ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203013 ↗
• MalfunctionMar 19, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO SSU. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. A NEW PATIENT SAMPLE WAS ALSO COLLECTED AFTER TWO HOURS. THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 8.12 MIU/ML. THE FIRST REPEAT RESULT OF THE INITIAL SAMPLE WAS >100 MIU/ML. THE SECOND REPEAT RESULT OF THE INITIAL SAMPLE WAS 122 MIU/ML. THIS REPEAT RESULT WAS DEEMED CORRECT.  THE RESULT OF THE NEW SAMPLE WAS 94.9 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928796 ↗
• MalfunctionMar 12, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON 03-FEB-2024: THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 22.2 UIU/ML. ON (B)(6) 2024: THE PATIENT WENT TO ANOTHER LABORATORY WHERE THEY HAD A REPEAT BLOOD SAMPLING. THE RESULT OF THIS NEW SAMPLE WAS REPORTEDLY NORMAL (AROUND 1 UIU/ML). THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 11.7 UIU/ML. THE REPORTER IS CONCERNED ABOUT THE OCCURRENCE OF MACRO TSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884380 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 MODULE. THE RESULTS DID NOT AGREE WITH THE RESULTS FROM A COMPETITOR ASSAY AS THE VALUES SHOWED DIFFERENT CLINICAL INTERPRETATIONS IN RELATION TO THE RESPECTIVE ASSAY REFERENCE RANGES. THE CUSTOMER ALLEGED THAT MULTIPLE MEASUREMENTS WERE PERFORMED WITH SAMPLES COLLECTED FROM THE PATIENT, INCLUDING MEASUREMENTS PERFORMED WITH ELECSYS TSH AND THREE COMPETITOR DEVICES. THE CUSTOMER SUSPECTS AN UNKNOWN SAMPLE INTERFERENCE, AS THE RESULTS WERE COMPARABLE BUT CLINICALLY NOT PLAUSIBLE FOR THE PATIENT'S MEDICAL HISTORY (FT4 AND FT3 ARE ALSO ELEVATED). REFER TO THE ATTACHMENT FOR THE PATIENT DATA. THE SAMPLE/RESULT IN QUESTION IS HIGHLIGHTED IN YELLOW (SAMPLE 11).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828221 ↗
• MalfunctionFeb 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 ANALYTICAL UNIT IN COMPARISON TO RESULTS OBTAINED ON A COMPETITOR PLATFORM. THE SAMPLE WAS TESTED TWICE ON THE E801 ANALYZER, RESULTING IN TSH VALUES OF 0.011 UIU/ML AND 0.011 UIU/ML. THE SAMPLE WAS ALSO TESTED TWICE ON THE COMPETITOR PLATFORM, RESULTING IN TSH VALUES OF 1.012 UIU/ML AND 1.012 UIU/ML. THE RESULTS MEASURED ON THE COMPETITOR PLATFORM WERE BELIEVED TO THE CORRECT VALUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702716 ↗
• MalfunctionJan 16, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TSH ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INITIAL RESULT WAS >100 MIU/L. THE RESULT FROM AN ABBOT ANALYZER WAS 0.04 MIU/L. THE RESULT AFTER USING PEG PRECIPITATION WAS 0.284 MIU/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516839 ↗
• MalfunctionDec 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340406 ↗
• MalfunctionNov 15, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 MODULE. THE CUSTOMER STATED THAT THE RESULT OBTAINED WITH THE ROCHE METHOD DOES NOT MATCH THE PATIENT'S CLINICAL PICTURE OF HYPERTHYROIDISM. MEASUREMENTS OF THE SAME PATIENT OBTAINED WITH A COMPETITOR METHOD MATCH THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER STATED THAT DISCREPANCIES BETWEEN ROCHE AND THE COMPETITOR HAVE OCCURRED BEFORE WITH OTHER SAMPLES FROM THE SAME PATIENT STARTING IN 2020. NO SPECIFIC RESULTS WERE PROVIDED RELATED TO THIS ALLEGATION. THE SAMPLE IN QUESTION RESULTED IN A TSH VALUE OF 2.29 UUI/ML (REFERENCE RANGE = 0.27 - 4.20 UUI/ML) WHEN TESTED WITH THE ROCHE METHOD ON 20-OCT-2023. THE SAMPLE WAS REPEATED WITH THE COMPETITOR METHOD ON 20-OCT-2023, RESULTING IN A TSH VALUE OF 0.007 UUI/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144452 ↗
• MalfunctionNov 3, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS THYROID-STIMULATING HORMONE (TSH) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 0.0265 MIU/L REPEAT RESULT: 0.514 MIU/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066291 ↗
• MalfunctionOct 30, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THIS MDR IS FOR THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-(B)(6) FOR THE FT4 IV ASSAY. THE INITIAL RESULTS WERE REPORTED TO THE DOCTOR. ON 04-SEP-2023, THE INITIAL TSH RESULT WAS 0.021 IU/ML. ON 07-SEP-2023, THE REPEAT RESULT WAS 2.42 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028334 ↗
• MalfunctionOct 13, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 ANALYTICAL UNIT. THE TSH RESULTS WERE CONSIDERED TOO HIGH AND THE CUSTOMER SUSPECTS THE SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST A COMPONENT OF THE TSH ASSAY. THE SAMPLE ALSO HAD DISCREPANT RESULTS FOR ELECSYS FT3 III WHEN COMPARED TO THE FT3 VALUE MEASURED ON A COMPETITOR SYSTEM (SIEMENS). THIS MEDWATCH WILL APPLY TO THE TSH ASSY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6)FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS TESTED AT THE CUSTOMER SITE ON (B)(6) 2023. THE SAMPLE WAS REPEATED FOR TSH ON THE E801 ANALYZER AFTER A X10 AUTOMATIC DILUTION. TSH WAS ALSO RE-MEASURED ON THE E801 ANALYZER AFTER BEING DILUTED X2 AND TREATED WITH POLYETHYLENE GLYCOL (PEG). THE SAMPLE WAS REPEATED FOR TSH AND FT3 ON A SIEMENS ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931397 ↗
• MalfunctionSep 29, 2023High Test Results; Chemical Problem; Improper Chemical Reaction; High Test Results; Chemical Problem; Improper Chemical Reaction

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH (TSH) ON TWO COBAS 8000 E 801 MODULES COMPARED TO THE SIEMENS METHOD. THE INITIAL RESULT FROM E801 MODULE A WAS 19.90 UIU/ML. THE REPEAT RESULT FROM E801 MODULE B WAS 23.50 UIU/ML. THE SAMPLE WAS SENT TO ANOTHER HOSPITAL USING THE SIEMENS VISTA METHOD AND THE RESULT WAS <0.005 UIU/ML. THE CUSTOMER SUSPECTS AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847693 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE VALUES FOR SIX PATIENT SAMPLES TESTED WITH THYROID ASSAYS ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS TSH, ELECSYS FT4 IV, AND ELECSYS FT3 III. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE VALUES HIGHLIGHTED IN YELLOW WERE QUESTIONED. SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON AN UNKNOWN DATE. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2023. THE SAMPLES WERE REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785465 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE VALUES FOR SIX PATIENT SAMPLES TESTED WITH THYROID ASSAYS ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS TSH, ELECSYS FT4 IV, AND ELECSYS FT3 III. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE VALUES HIGHLIGHTED IN YELLOW WERE QUESTIONED. SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON AN UNKNOWN DATE. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON 25-AUG-2023. THE SAMPLES WERE REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON 29-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785450 ↗
• MalfunctionSep 6, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TSH (TSH) ON A COBAS E 801 MODULE. THE PATIENT WAS TESTED ON (B)(6) 2023 AND (B)(6) 2023 WITH TSH RESULTS GREATER THAN 100 UIU/ML ON THE E801 MODULE. THESE RESULTS WERE FROM SEPARATE SAMPLES. THE HIGH RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE SAMPLE FROM (B)(6) 2023 WAS TESTED BY THE SIEMENS METHOD AND THE TSH RESULT WAS WITHIN THE REFERENCE RANGE (APPROXIMATELY 5 UIU/ML).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693602 ↗
• MalfunctionAug 17, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 IV (FT4 IV) AND ELECSYS FT3 III (FT3 III). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE ADDITIONAL TESTING WAS REQUESTED. THE SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH AND FT4 BETWEEN THE CUSTOMER¿S E801 MODULE, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE AND THE ABBOTT ARCHITECT METHOD. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS. REFER TO THE ATTACHED FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568008 ↗
• MalfunctionAug 17, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 IV (FT4 IV) AND ELECSYS FT3 III (FT3 III). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE ADDITIONAL TESTING WAS REQUESTED. THE SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH, FT4 AND FT3 III BETWEEN THE CUSTOMER¿S E801 MODULE, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE AND THE ABBOTT ARCHITECT METHOD. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. REFER TO THE ATTACHED FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567063 ↗