Elecsys FT3 III 07027362190Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 04015630939718), received between Jul 12, 2018 and Jan 24, 2025 — classified as 1 injury, 110 malfunctions.

The most frequently reported specific device problem is “High Test Results” (89 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 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE FT3 G3 ELECSYS E2G RESULTS FOR 1 PATIENT FROM THE COBAS 8000 CORE UNIT, 2 PATIENTS FROM COBAS 8000 - COBAS E 602 MODULES, AND 2 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 37-85 YEARS, 3-ASKU, 3. PATIENT WEIGHT RANGE: 5-ASKU, 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 3-ASKU, 5. PATIENT RACE BREAKDOWN: 5-ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 5-ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232797 ↗
• MalfunctionOct 24, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 13 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III ON 6 COBAS E 801 ANALYTICAL UNITS, TWO COBAS E411 ANALYZERS, ONE COBAS 6000 E601 MODULE, TWO COBAS 8000 CORE UNITS, AND ONE COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: 5 PATIENTS ARE 28 - 70, 8 PATIENTS ARE ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 3 FEMALES, 2 MALES, 8 ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525311 ↗
• MalfunctionApr 16, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III (FT3 III) AND ELECSYS FT3 III VER. 2 (FT3 III V 2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MSB/MSBL. THE REPORTER SUSPECTS THE INITIAL RESULT WAS A FALSE POSITIVE CAUSED BY AN INTERFERENCE IN THE PATIENT SAMPLE. THIS MDR IS FOR THE FT3 III ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR THE FT3 III V 2 ASSAY PLEASE REFER TO THE ATTACHMENT PT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118960 ↗
• MalfunctionMar 19, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 III ASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A SIEMENS ANALYZER AND AN ABBOTT ARCHITECT ANALYZER. THE CUSTOMER ALSO STATES THAT THE ROCHE RESULTS DO NOT MATCH THE PATIENT'S CLINICAL PICTURE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-00067637 FOR INFORMATION ON THE FT4 III RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932052 ↗
• MalfunctionFeb 7, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3 III) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 40.3 PMOL/L. THE REPEAT RESULT WAS 4.81 PMOL/L. PATIENT 2 INITIAL RESULT WAS 10.8 PMOL/L. THE REPEAT RESULT WAS 4.10 PMOL/L. PATIENT 3 INITIAL RESULT WAS 9.88 PMOL/L. THE REPEAT RESULT WAS 4.99 PMOL/L. PATIENT 4 INITIAL RESULT WAS 7.27 PMOL/L. THE REPEAT RESULT WAS 5.85 PMOL/L. PATIENT 5 INITIAL RESULT WAS 7.70 PMOL/L. THE REPEAT RESULT WAS 5.41 PMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659208 ↗
• MalfunctionAug 11, 2023High Test Results; Chemical Problem; High Test Results; Chemical Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III RESULT FROM ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNITS. THE INITIAL RESULT WAS REPORTED TO THE PATIENT. THE REPORTER WOULD LIKE TO VERIFY IF THE RESULTS FROM THE E 801 WERE FALSELY HIGH RESULTS. THE PATIENT SAMPLE WAS ALSO RERUN ON AN ABBOTT ANALYZER. ON 12-JUL-2023, THE INITIAL RESULT FROM THE FIRST E 801 WAS 9.01 PG/ML. ON 13-JUL-2023, THE REPEAT RESULT FROM THE SECOND E 801 WAS 8.50 PG/ML. THE REPEAT RESULT FROM THE ABBOTT ANALYZER WAS LESS THAN 1.07 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511311 ↗
• MalfunctionJun 23, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT3 G3 (FT3 III) ASSAY ON A COBAS E801 ANALYTICAL UNIT COMPARED TO A NON-ROCHE ANALYZER (ABBOTT). REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. THE PHYSICIAN DOUBTED THE FT3 III RESULT AND LATER THAT DAY, HE ORDERED A NEW FT3 III TEST USING A NEW SAMPLE. THEN 3 SAMPLES WERE COLLECTED FROM THE SAME PATIENT AT DIFFERENT TIME POINTS AND TESTED. THE SAMPLE WAS THEN SENT TO A DIFFERENT LABORATORY AND WAS TESTED ON AN ABBOTT ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194398 ↗
• MalfunctionMay 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS, 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 T3 RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955702 ↗
• MalfunctionMar 23, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III ASSAY AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER: (B)(4), THE INVESTIGATION SITE'S E 411 WITH SERIAL NUMBER: (B)(4) AND THE INVESTIGATION SITE'S E 801 WITH SERIAL NUMBER: (B)(4). THIS MEDWATCH IS FOR THE FT3 III ASSAY. PLEASE REFER TO MEDWATCH WITH PATIENT IDENTIFIER: (B)(6) FOR THE FT3 III V2 ASSAY. THE REPORTER ALLEGED THAT THE FT3 RESULT DID NOT MATCH THE PATIENT'S CLINICAL SITUATION AND THAT THE THYROID DATA WERE IMBALANCED. THE REPORTER SUSPECTS A FALSELY HIGH FT3 RESULT AND SOME NONSPECIFIC INTERFERENCE IN ROCHE ASSAYS. THE REPORTER REQUESTED MEASUREMENT OF THE PATIENT SAMPLE AT AN INVESTIGATION SITE. IT WAS ALSO SENT OUT TO AN OUTSOURCED LABORATORY. THE REPORTER WAS NOT ABLE TO PROVIDE THE DATE OF MEASUREMENT AT THE CUSTOMER SITE. THE DATE OF BLOOD SAMPLING WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PLEASE REFER TO THE ATTACHMENT "PT-80290 " FOR THE HIGHLIGHTED QUESTIONABLE RESULTS. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 585947 WITH AN EXPIRATION DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603204 ↗
• MalfunctionMar 20, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 4 PATIENT SAMPLES TESTED WITH THE ELECSYS TSH, THE ELECSYS FT4 III, AND THE ELECSYS FT3 III VER.2 (FT3 V2) ASSAY ON MULTIPLE ROCHE ANALYZERS AND COMPARED TO THE ABBOTT ARCHITECT METHOD. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. THE SAMPLES WERE INITIALLY TESTED WITH TSH, FT4 III, AND FT3 V2 ON THE CUSTOMER'S COBAS E 801 MODULE ON AN UNKNOWN DATE. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED WITH THE TSH, FT4 III, AND FT3 V2 ASSAYS ON A SECOND E 801 MODULE ON (B)(6) 2023. DURING INVESTIGATIONS, THE SAMPLES WERE ALSO TESTED WITH THE TSH, FT4 III AND FT3 V2 ASSAYS ON A COBAS E 411 ANALYZER ON (B)(6) 2023. THE SAMPLES WERE ALSO REPEATED USING THE ABBOTT ARCHITECT TSH, FT4 AND FT3 METHODS ON (B)(6) 2023. REFER TO THE ATTACHMENT FOR ALL RELEVANT TEST DATA. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575790 ↗
• MalfunctionFeb 24, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E801 MODULE. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED ADDITIONAL TESTING. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT3 III (FT3 III) AND ELECSYS TSH (TSH) 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 FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. THE CUSTOMER¿S E801 MODULE WAS 1752-03. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION WAS 611920 WITH AN EXPIRATION DATE OF 31-MAY-2023. THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER AT THE INVESTIGATION WAS 573234 WITH AN EXPIRATION DATE OF 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439748 ↗
• MalfunctionFeb 10, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S E 411 ANALYZER WITH SERIAL NUMBER (B)(4). THIS MDR IS FOR THE FT3 III ASSAY. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III V2 ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER SUSPECTED SOME NONSPECIFIC INTERFERENCE IN THE ROCHE ASSAYS. THE PATIENT SAMPLES WERE THEN SENT TO AN INVESTIGATION SITE THAT USES AN E 411 AND AN E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 585947 WITH AN EXPIRATION DATE OF 28-FEB-2023. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 583301 WITH AN EXPIRATION DATE OF 28-FEB-2023. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16356285 ↗
• MalfunctionFeb 7, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO AN ACURASEED WAKO ANALYZER AND AN ABBOTT ARCHITECT ANALYZER. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III VER.2 RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315288 ↗
• MalfunctionFeb 6, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III VER. 2 (FT3 III V 2) ON TWO COBAS E 801 MODULES. THE SAMPLE ALSO HAD DISCREPANT RESULTS FOR ELECSYS FT3 III (FT3 III) WHEN TESTED ON THE SECOND E 801 MODULE THAT WAS USED FOR INVESTIGATION. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III V 2 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. QUESTIONED VALUES ARE HIGHLIGHTED IN YELLOW. THE SAMPLE WAS INITIALLY TESTED WITH THE FT3 II V 2 ASSAY WHEN TESTED ON THE CUSTOMER'S E 801 MODULE ON (B)(6) 2023. THE SAMPLE WAS REPEATED BY THE CUSTOMER USING THE WAKO ACCURASEED FT3 METHOD. THE CUSTOMER ALSO TREATED THE SAMPLE WITH POLYETHYLENE GLYCOL (PEG) AND REPEATED IT ON THEIR E 801 MODULE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED WITH FT3 III AND FT3 III V 2 ON A SECOND E 801 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED USING THE ABBOTT ARCHITECT FT3 METHOD ON (B)(6) 2023. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 MODULE IS (B)(4). FT3 II

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308222 ↗
• MalfunctionJan 5, 2023High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4). THIS MDR IS FOR THE FT3 III ASSAY. REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT3 III V2 ASSAY. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN ASKED FOR THE SAMPLE TO BE RERUN AT THE INVESTIGATION SITE. THE INVESTIGATION SITE USES AN E 411 AND E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. THE FT3 III REAGENT WAS USED AT THE INVESTIGATION SITE'S E 801. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101240 ↗
• MalfunctionJan 4, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO A FUJIREBIO LUMIPULSE ANALYZER. THE CUSTOMER SUSPECTED A NON-SPECIFIC INTERFERENCE IN A PATIENT SAMPLE AND REFERRED IT FOR INVESTIGATION. A TEST RESULT DISCREPANCY WAS GENERATED DURING THE INVESTIGATIONAL MEASUREMENTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER E801 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(4). THE CUSTOMER REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III VER.2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094278 ↗
• MalfunctionDec 21, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH, ELECSYS FT4 III, ELECSYS FT3 III (FT3), AND THE ELECSYS FT3 III VER. 2 (FT3 V2) ASSAYS ON MULTIPLE ROCHE ANALYZERS AND A COMPETITOR INSTRUMENT. IT WAS ASKED BUT IT IS UNKNOWN IF QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 V2 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. THE SAMPLE WAS COLLECTED ON (B)(6) 2022 AND INITIALLY TESTED WITH TSH, FT3 V2, AND FT4 ON THE CUSTOMER'S COBAS E 801 MODULE ON (B)(6) 2022. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED WITH THE TSH, FT4 III, FT3 AND FT3 V2 ASSAYS ON A SECOND E801 ANALYZER ON (B)(6) 2022. DURING INVESTIGATIONS, THE SAMPLE WAS ALSO TESTED WITH THE FT3 AND FT3 V2 ASSAYS ON A COBAS E 411 ANALYZER ON (B)(6) 2022. ON (B)(6) 2022, THE CUSTOMER PROVIDED ADDITIONAL DATA, SHOWING TSH, FT4, AND FT3 RESULTS OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024073 ↗
• MalfunctionDec 20, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III V2 ASSAY (FT3 V2) ON 2 COBAS 8000 E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLE ALSO HAD DISCREPANT RESULT FOR THE ELECSYS FT3 III (FT3) ASSAY ON ONE OF THE TWO E 801 MODULES. THE SPECIFIC DATE OF THE EVENT IS UNKNOWN. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 V2 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER. THE SAMPLE WAS THE PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E 801 ANALYZER AND E 411 ANALYZER ON 30-NOV-2022. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON 6-DEC-2022. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF E 801 ANALYZER USED FOR INVESTIGATION IS 14D9-06. THE FT3 REAGENT LOT NUMBER WAS 583301 WITH AN EXPIRATION DATE OF 28-FEB-2023. THE SERIAL NUMBER OF E 411 ANALYZER USED FOR INVESTIGATION IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016817 ↗
• MalfunctionDec 20, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT FROM A COBAS E 801 MODULE COMPARED TO ANOTHER E801 MODULE AND A COBAS E411 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AND THE SAMPLE WAS SENT OUT FOR INVESTIGATION. THE DATE OF THE CUSTOMER'S MEASUREMENTS WAS NOT PROVIDED. THE CUSTOMER E801 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(4). THE INVESTIGATIONAL E411 ANALYZER SERIAL NUMBER IS (B)(4). THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III VER.2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016807 ↗
• MalfunctionDec 16, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH VER. 2 ASSAY, ELECSYS FT4 III ASSAY, ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FOR 2 PATIENT SAMPLES TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S COBAS E 411 MODULE WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4). THIS MDR IS FOR THE FT3 III ASSAY. REFER TO: MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III V2 ASSAY; MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY; MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TSH V2 ASSAY. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE SENT TO AN INVESTIGATION SITE THAT USES AN E 411 AND E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. THE FT3 III REAGENT WAS USED AT THE INVESTIGATION SITE'S E 801.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996845 ↗
• MalfunctionDec 8, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E801 MODULE COMPARED TO A WAKO ACCURASEED ANALYZER AND AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REAGENT LOTS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL FT3III LOT IS 583301 AND THE EXPIRATION DATE IS 28-FEB-2023. THE INVESTIGATIONAL FT3III VER.2 LOT IS 611920 AND THE EXPIRATION DATE IS 31-MAY-2023. THE CUSTOMER E801 ANALYZER SERIAL NUMBER IS (B)(4). THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(4). THIS MEDWATCH WILL COVER FT3III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3III VER.2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939197 ↗
• MalfunctionNov 11, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 E 801 MODULE WITH AN UNKNOWN SERIAL NUMBER AND THE INVESTIGATION SITE'S COBAS 8000 E 801 MODULE WITH SERIAL NUMBER (B)(6). THIS MDR IS FOR THE FT3 III ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III V2 ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER SENT THE PATIENT SAMPLE TO THE INVESTIGATION SITE DUE TO AN IMBALANCE OF THYROID TEST RESULTS. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT FOR RERUNS. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780879 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE THYROID ASSAY RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT TESTED ON A COBAS 8000 E 801 MODULE. RESULTS FROM THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS T3, THE ELECSYS T4 ASSAY, ELECSYS FT3 III, THE ELECSYS FT4 ASSAY, ROCHE DIAGNOSTICS ELECSYS ANTI-TG, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO. THE THYROID RESULTS WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR AND PATIENT. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TPO ASSAY. THE SAMPLE FROM (B)(6) 2022 WAS REPEATED ON (B)(6) 2022. AN EXPERIMENT WAS ALSO PERFORMED WITH THE SAMPLE FROM (B)(6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728962 ↗
• MalfunctionOct 29, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO ANOTHER E801 MODULE, AN E411 MODULE, AND AN ABBOTT ARCHITECT. IT IS NOT KNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER'S E801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E401 MODULE'S SERIAL NUMBER IS (B)(4). THE FT3 REAGENT LOT USED WAS 585947. THE INVESTIGATIONAL E801 MODULE'S SERIAL NUMBER IS (B)(4). THE FT3 REAGENT LOT USED WAS 583301 AND THE EXPIRATION DATE IS 28-FEB-2023. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS AND A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III VER.2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694502 ↗
• MalfunctionOct 25, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT3 III VER.2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 E801 MODULE WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S COBAS 8000 E801 MODULE WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S E 411 WITH SERIAL NUMBER (B)(4). THIS MDR IS FOR THE FT3 III ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III V2 ASSAY. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER SUSPECTED NON-SPECIFIC INTERFERENCE IN THE ROCHE THYROID ASSAYS. THE PATIENT SAMPLE WAS THEN RERUN IN THEIR WAKO ACCURASEED ANALYZER. IT WAS ALSO SENT TO THE INVESTIGATION SITE AND AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. THE FT3 III REAGENT LOT USED IN THE INVESTIGATOR SITE'S E 801 IS 551720 WITH AN EXPIRATION DATE OF (B)(6) 2022. THE FT3 III REAGENT LOT USED IN THE INVESTIGATOR SITE'S E 411 IS 585947 WITH AN EXPIRATION DATE OF (B)(6) 2022. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670177 ↗