Elecsys FT3 III 09005803190Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613336171585), received between Apr 8, 2022 and Apr 27, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM) AND ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO THE ABBOTT ASSAY. 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 25002175 ↗
• MalfunctionApr 27, 2026High Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002174 ↗
• MalfunctionJul 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS FT3 III ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT AGE RANGE: ASKU. PATIENT WEIGHT RANGE: ASKU. PATIENT SEX BREAKDOWN: ASKU. PATIENT RACE BREAKDOWN: ASKU. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586707 ↗
• MalfunctionJan 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 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 21232801 ↗
• MalfunctionApr 26, 2024Low Test Results; Output Problem; Non Reproducible Results; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT USING THE PRIMARY SAMPLE TUBE WAS 4.58 PG/ML. THE REPEAT RESULT PERFORMED IN A SAMPLE CUP WAS 26 PG/ML. THE RESULT USING THE PRIMARY SAMPLE TUBE FROM A NEW VENIPUNCTURE OF THE PATIENT WAS 25 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191752 ↗
• MalfunctionJan 30, 2024Incorrect, 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 FT3 III RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 E 601 MODULE. THE CUSTOMER QUESTIONED THE HIGH INITIAL AND REPEAT RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL HISTORIES AND WAS PROMPTED TO CHANGE THE REAGENT PACK AND REPEAT THE SAMPLES AGAIN. FOR PATIENT 1, THE INITIAL FT3 RESULT WAS 12.8 PMOL/L. THE SAMPLE WAS AUTO-REPEATED AND THE RESULT WAS 12.9 PMOL/L. THE SAMPLE WAS REPEATED AGAIN WITH A DIFFERENT REAGENT PACK AND THE RESULT WAS ESTIMATED TO BE 2-3 PMOL/L. FOR PATIENT 2, THE INITIAL FT3 RESULT WAS 10.8 PMOL/L. THE SAMPLE WAS AUTO-REPEATED AND THE RESULT WAS 11.95 PMOL/L. THE SAMPLE WAS REPEATED AGAIN WITH A DIFFERENT REAGENT PACK AND THE RESULT WAS ESTIMATED TO BE 2-3 PMOL/L. NO QUESTIONABLE RESULTS FROM PATIENT 2 WERE REPORTED OUTSIDE OF THE LABORATORY. THE ESTIMATED RESULTS OF 2-3 PMOL/L WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607939 ↗
• MalfunctionJan 12, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E411 MODULE. THE INITIAL RESULT WAS 4.5 PG/ML. THE SAMPLE WAS RETESTED, BUT THE RESULT DID NOT CHANGE. THE CUSTOMER PERFORMED CALIBRATION AND REPEATED THE SAMPLE. THE REPEATED RESULT, AFTER CALIBRATION, WAS 3.6 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507429 ↗
• MalfunctionOct 12, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE COMPARED TO AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE FT3 G3 ELECSYS ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FT4 G4 ELECSYS ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921338 ↗
• MalfunctionSep 29, 2023High Test Results; Low Test Results; Output Problem; Non Reproducible Results; High Test Results; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ELECSYS FT3 III AND ELECSYS TOTAL PSA IMMUNOASSAY FOR 2 PATIENT SAMPLES ON A COBAS E 602 MODULE. ON (B)(6) 2023, SAMPLE 1 HAD AN INITIAL FT3 RESULT OF 7.58 PMOL/L. ON (B)(6) 2023, THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 4.29 PMOL/L. ON (B)(6) 2023, SAMPLE 2 HAD AN INITIAL PSA RESULT OF 0.594 UG/L. ON (B)(6) 2023, THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 0.794 UG/L OR 0.793 UG/L. CLARIFICATION ON WHICH RESULT WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843026 ↗
• MalfunctionSep 25, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III AND FT3 III ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE FT3 III ASSAY. PLEASE REFER TO A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEIR LABORATORY SUPERVISOR DEEMED THE RESULTS REPORTED BY ROCHE COBAS E601 DID NOT MEET CLINICAL EXPECTATIONS AND WERE UNEXPLAINABLE. THEY CONSIDERED THAT THERE WAS AN INTERFERENCE IN THE FT3 & FT4 ELECTROCHEMILUMINESCENCE IMMUNOASSAYS (ECLIA) THAT LED TO THE ELEVATED RESULTS. THE PATIENT SAMPLE WAS SENT TO TWO OTHER LABORATORIES: LABORATORY 1, WHICH USES A BECKMAN DXI 800 ANALYZER AND LABORATORY 2, WHICH USES AN ABBOTT ARCHITECT. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806485 ↗
• MalfunctionSep 21, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO COMPETITOR METHODS. DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT4 IV (FT4 IV), ELECSYS FT3 III (FT3 III), AND ELECSYS ANTI-TSHR (ANTI-TSHR) BETWEEN THE CUSTOMER¿S E411 ANALYZER, THE ABBOTT ALINITY METHOD, THE FUJIREBIO LUMIPULSE METHOD AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 IV RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TSHR RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789391 ↗
• MalfunctionSep 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON A COBAS 6000 E601 MODULE. THE ISSUE OCCURRED WHEN STARTING TO USE A NEW REAGENT KIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN FT3 VALUE OF 32.55 PG/ML. THE SAMPLE DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 2.67 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694934 ↗
• MalfunctionAug 31, 2023High Test Results; Insufficient Device Problem Information; High Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 III (FT4 III) AND ELECSYS FT3 III (FT3 III) ON A COBAS 8000 E 602 MODULE COMPARED TO OTHER METHODS. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. THE FT4 III RESULT FROM THE E602 MODULE WAS 24.11 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE BECKMAN METHOD WAS 0.64 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE AUTIBIO METHOD WAS 14.47 PMOL/L. THE FT3 III RESULT FROM THE E602 MODULE WAS 10.57 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE BECKMAN METHOD WAS 3.30 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE AUTIBIO METHOD WAS 5.55 PMOL/L. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661753 ↗
• MalfunctionAug 15, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY, ELECSYS FT4 III ASSAY, ELECSYS FT3 III ASSAY AND ELECSYS FT4 IV ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 6000 E 601 WITH SERIAL NUMBER (B)(6) AND THE INVESTIGATION SITE'S COBAS 6000 E 601 WITH SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE DATE OF BLOOD SAMPLING WAS USED AS THE DATE OF EVENT. THE REPORTER SUSPECTED ABNORMAL TSH RESULTS IN THE ROCHE ASSAYS. THEY THEN SENT THE PATIENT SAMPLE TO THE INVESTIGATION LABORATORY AND SUBSEQUENTLY SUBMITTED THE PATIENT SAMPLE TO AN OUTSOURCED LABORATORY FOR FURTHER INVESTIGATION. THIS MDR IS FOR THE FT3 III V2 ASSAY. PLEASE REFER TO: MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY. MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552242 ↗
• MalfunctionAug 11, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS TSH, ELECSYS FT3 III, AND THE ELECSYS FT4 IV ASSAY ON A COBAS 6000 E601 MODULE. THE QUESTIONABLE RESULTS DO NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE FIRST SAMPLE WAS ALSO TESTED ON A COBAS E 801 ANALYZER. THE SECOND SAMPLE WAS ALSO TESTED USING THE ABBOTT ARCHITECT TSH, FT3 AND FT4 METHODS. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND TO THE MEDWATCH WTH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL RELEVANT TEST DATA. THE SERIAL NUMBER OF THE CUSTOMER'S E 601 ANALYZER WAS (B)(6). THE SERIAL NUMBER OF THE CUSTOMER¿S E 801 WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515297 ↗
• MalfunctionAug 10, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS FT3 G3 ASSAY ON A COBAS 6000 E 601 IMMUNOASSAY ANALYZER. INITIAL RESULT: 17.6 PG/ML REPEAT RESULT: 1.78 PG/ML. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504464 ↗
• MalfunctionJul 24, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH, ELECSYS FT3 III, ELECSYS FT4 III, AND ELECSYS FT4 IV ON A COBAS E411 DISK AND A COBAS E411 RACK. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE VALUES HIGHLIGHTED IN YELLOW ARE QUESTIONABLE. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E411 DISK ANALYZER ON (B)(6) 2023. THE SAMPLE WAS REPEATED USING THE ABBOTT ARCHITECT METHOD. THE CUSTOMER PERFORMED ADDITIONAL DILUTION STUDY MEASUREMENTS WITH THE TSH ASSAY ON THEIR E411 DISK ANALYZER, INCLUDING 1:5, 1:10, 1:20, 1:50, AND 1:100 DILUTIONS. THE CUSTOMER ALSO TREATED THE SAMPLE WITH A 25 % POLYETHYLENE GLYCOL SOLUTION AND REPEATED TSH, FT3 III, AND FT4 III MEASUREMENTS ON THE E411 DISK ANALY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383582 ↗
• MalfunctionJul 19, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III, ELECSYS FT4 IV AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6) AND THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6). THIS MDR IS FOR THE FT3 III V2 ASSAY. REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. 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 REQUESTED THAT THE SAMPLE BE SENT TO THE INVESTIGATION SITE. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES A FUJIREBIO LUMIPULSE ANALYZER. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH (B)(6) FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356037 ↗
• MalfunctionJun 21, 2023Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH ELECSYS FT3 G3 (FT3 III) ASSAY ON A COBAS E601 IMMUNOASSAY ANALYZER WHEN COMPARED TO ANOTHER COBAS E601 IMMUNOASSAY ANALYZER. THE CUSTOMER REPORTED A >25 PG/ML WHICH WAS ACCOMPANIED BY A DATA FLAG >TEST. THE CUSTOMER DID NOT REALIZE THAT THE INSTRUMENT NEEDED TO DILUTE THE SAMPLE AND THE DILUTED VALUE WAS 7.5 PG/ML . THE REPEAT RESULT WAS 2.5 PG/ML (ON A DIFFERENT E601) WHICH WAS DEEMED CORRECT. THE LABORATORY IS IN THE PROCESS OF CORRECTING THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17177472 ↗
• MalfunctionJun 16, 2023High Test Results; Optical Problem; High Test Results; Optical Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON A COBAS E411 RACK. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED IN A FT3 VALUE OF 7.39 PG/ML WHEN TESTED ON THE E411 ANALYZER. THE SAMPLE WAS REPEATED ON A VIDAS ANALYZER, RESULTING IN A FT3 VALUE OF 4.0 PG/ML (REFERENCE RANGE = 2.6 - 5.5 PG/ML). THE CUSTOMER DEEMED THIS VALUE TO BE CORRECT. THE SAMPLE WAS ALSO REPEATED ON THE E411 ANALYZER, RESULTING IN A FT3 VALUE OF 6.48 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145421 ↗
• MalfunctionJun 5, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS TSH V2 (TSH V2) ASSAY, ELECSYS FT4 G4 (FT4 IV) ASSAY AND ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS E801 MODULE AND ON A COBAS E411 MODULE. FROM THE SAMPLE, THERE WERE 1 DISCREPANT RESULT FOR TSH V2 TEST, 1 DISCREPANT RESULT FOR FT4 IV TEST AND 1 DISCREPANT RESULT FOR FT3 III V2 TEST. THIS MEDWATCH WILL APPLY TO THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH V2 ASSAY AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. ON 27-APR-2023 THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER AND REPEATED ON THE SAME ANALYZER. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON 28-APR-2023 THE SAMPLE WAS THEN PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER AND ON AN E411 ANALYZER. ON 9-MAY-2023 THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER. THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER AND EXPIRATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064977 ↗
• MalfunctionMar 23, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SAMPLES FROM TWO PATIENTS TESTED WITH THE ELECSYS FT3 III ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. PATIENT 1: THE SAMPLE INITIALLY RESULTED IN AN FT3 III VALUE OF 39.18 PMOL/L. ON (B)(6) 2023, A NEW SAMPLE FROM THE PATIENT RESULTED IN AN FT3 III VALUE OF 4.54 PMOL/L. PATIENT 2: THE SAMPLE INITIALLY RESULTED IN AN FT3 III VALUE OF 42.21 PMOL/L. ON (B)(6) 2023, A NEW SAMPLE FROM THE PATIENT RESULTED IN AN FT3 III VALUE OF 4.95 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600168 ↗
• MalfunctionFeb 28, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE AND A COBAS 8000 ANALYZER. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. THE INITIAL FT3 RESULTS WERE 18.0 PMOL/L AND 18.04 PMOL/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE FT4 III RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A COBAS 8000 ANALYZER AND THE FT3 RESULT WAS 11.5 PMOL/L. THE SAMPLE WAS SENT TO A THIRD LABORATORY AND TESTED ON A COBAS 8000 ANALYZER AND THE FT3 RESULT WAS 10.8 PMOL/L. THE CUSTOMER'S E601 ANALYZER SERIAL NUMBER IS (B)(4). THE COBAS 8000 ANALYZER SERIAL NUMBERS FROM THE OTHER TWO LABORATORIES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453990 ↗
• MalfunctionFeb 14, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III ASSAY AND ELECSYS FT3 III VER.2 RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE CUSTOMER'S COBAS 8000, COBAS E 602 MODULE WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S E 411 WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S E 601 WITH SERIAL NUMBER (B)(4). THIS IS FOR THE FT3 III ASSAY. PLEASE REFER TO WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. 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. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE CUSTOMER'S LABORATORY IS 573234. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 573234 WITH AN EXPIRATION DATE OF 31-JAN-2023. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 601 IS 573234 WITH AN EXPIRATION DATE OF 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373413 ↗
• MalfunctionDec 22, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III ASSAY, ELECSYS FT3 III AND ELECSYS FT3 III VER.2, AND ELECSYS ANTI-TSHR IMMUNOASSAY VER. 2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E411 RACK WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S COBAS 8000 E 411 MODULE WITH SERIAL NUMBER (B)(4). THIS MDR IS FOR THE FT3 III V2 ASSAY. REFER TO: MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III ASSAY. MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TSHR ASSAY. MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 III 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 SENT TO THE INVESTIGATION SITE AND AN OUTSOURCED LABORATORY THAT USES A FUJIREBIO LUMIPULSE ANALYZER. THE FT3 III V2 REAGENT LOT USED IN THE CUSTOMER SITE'S E 411 AND ITS EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT USED IN THE INVESTIGATOR SITE'S E 411 IS 567499 WITH AN EXPIRATION DATE OF 30-NOV-2022. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033932 ↗