MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07K65-29
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: patient 1, patient 2, patient 3, patient 4, patient 5, and patient 6.Section e1 - facility name: complete facility (b)(6) hospital.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
A literature article by angela d burns, christina kanonidou, and jane mcneilly, ¿misleading thyroid function tests in congenital dysfibrinogenemia¿, annals of clinical biochemistry 2024; 61.6: 474-479, documented imprecise architect free t4 results for 6 patients diagnosed with congenital dysfibrinogenemia.The following data was provided: patient 1 (89-year-old female with a history of graves¿ disease and thyroid eye disease): tsh result = 8.18 mu/l (reference range is 0.35 to 5.00 mu/l) free t4 = 12.1 pmol/l (reference range is 9.0 to 21.0 pmol/l).Based on these results, the patient¿s daily dose of carbimazole was reduced from 20 mg to 15 mg.After the dose titration, the patient had thyroid function tests measured on five separate occasions.In all of these instances the tsh results were significantly elevated, ranging between 11.2 and 23.6 mu/l and the ft4 measuring above or close to the top of the reference range, with results between 17.0 and 26.5 pmol/l.The clinicians managing the patient believed the results to be unusual with the patient displaying hypothyroidal symptoms rather than that of central hyperthyroidism as predicted by the thyroid function test results.A fresh serum sample was drawn to investigate the possibility of interference.The following data was provided: tsh initial result = 10.7 mu/l; repeat result = 13.4 mu/l (reference range is 0.35 to 5.00 mu/l) free t4 initial result = 13.4 pmol/l; repeat result = >64.4 pmol/l (reference range is 9.0 to 21.0 pmol/l.Upon visual inspection, small visible clot had formed.The clot was removed and the sample was repeated.Repeat tsh result after visible clots removed and re-centrifugation = 7.5 mu/l repeat free t4 result after visible clots removed and re-centrifugation = 11.4 pmol/l follow-up sample (serum) drawn two weeks later: tsh result = 3.2 mu/l free t4 result = 32.5 pmol/l follow-up sample (plasma) drawn two weeks later: tsh result = 10.2 mu/l free t4 result = 9.0 pmol/l roche cobas results (plasma): tsh result = 14.0 mu/l (reference range is 0.27 to 4.2 mu/l) free t4 result = 9.9 pmol/l (reference range is 12 to 22 pmol/l).It was noted that the results from the plasma sample were more in line with the patient¿s clinical presentation.Patient 2: serum free t4 result = >64.4 pmol/l; repeat serum post re-centrifugation = >64.4 pmol/l; plasma free t4 result = 18.2 pmol/l patient 3: serum free t4 result = 28.1 pmol/l; plasma free t4 result = 19.1 pmol/l patient 4: serum free t4 result = 31.8 pmol/l; plasma free t4 result = 14.2 pmol/l patient 5: serum tsh result = 0.46 mu/l; plasma tsh result = 0.31 mu/l serum free t4 result = >64.4 pmol/l; plasma free t4 result = 16.6 pmol/l patient 6: serum free t4 result = >64.4 pmol/l; repeat serum post re-centrifugation = 29.2 pmol/l; plasma (edta) free t4 result = 9.8 pmol/l it was noted that this patient was prescribed levothyroxine where the plasma result pointed towards insufficient thyroxine replacement.There was no further impact to patient management reported.
Event or Problem Description
A literature article by angela d burns, christina kanonidou, and jane mcneilly, ¿misleading thyroid function tests in congenital dysfibrinogenemia¿, annals of clinical biochemistry 2024; 61.6: 474-479, documented imprecise architect free t4 results for 6 patients diagnosed with congenital dysfibrinogenemia.The following data was provided: patient 1 (89-year-old female with a history of graves¿ disease and thyroid eye disease): tsh result = 8.18 mu/l (reference range is 0.35 to 5.00 mu/l), free t4 = 12.1 pmol/l (reference range is 9.0 to 21.0 pmol/l).Based on these results, the patient¿s daily dose of carbimazole was reduced from 20 mg to 15 mg.After the dose titration, the patient had thyroid function tests measured on five separate occasions.In all of these instances the tsh results were significantly elevated, ranging between 11.2 and 23.6 mu/l and the ft4 measuring above or close to the top of the reference range, with results between 17.0 and 26.5 pmol/l.The clinicians managing the patient believed the results to be unusual with the patient displaying hypothyroidal symptoms rather than that of central hyperthyroidism as predicted by the thyroid function test results.A fresh serum sample was drawn to investigate the possibility of interference.The following data was provided: tsh initial result = 10.7 mu/l; repeat result = 13.4 mu/l (reference range is 0.35 to 5.00 mu/l).Free t4 initial result = 13.4 pmol/l; repeat result = >64.4 pmol/l (reference range is 9.0 to 21.0 pmol/l.Upon visual inspection, small visible clot had formed.The clot was removed and the sample was repeated.Repeat tsh result after visible clots removed and re-centrifugation = 7.5 mu/l.Repeat free t4 result after visible clots removed and re-centrifugation = 11.4 pmol/l.Follow-up sample (serum) drawn two weeks later: tsh result = 3.2 mu/l.Free t4 result = 32.5 pmol/l.Follow-up sample (plasma) drawn two weeks later: tsh result = 10.2 mu/l.Free t4 result = 9.0 pmol/l.Roche cobas results (plasma): tsh result = 14.0 mu/l (reference range is 0.27 to 4.2 mu/l).Free t4 result = 9.9 pmol/l (reference range is 12 to 22 pmol/l).It was noted that the results from the plasma sample were more in line with the patient¿s clinical presentation.Patient 2: serum free t4 result = >64.4 pmol/l; repeat serum post re-centrifugation = >64.4 pmol/l; plasma free t4 result = 18.2 pmol/l.Patient 3: serum free t4 result = 28.1 pmol/l; plasma free t4 result = 19.1 pmol/l.Patient 4: serum free t4 result = 31.8 pmol/l; plasma free t4 result = 14.2 pmol/l.Patient 5: serum tsh result = 0.46 mu/l; plasma tsh result = 0.31 mu/l.Serum free t4 result = >64.4 pmol/l; plasma free t4 result = 16.6 pmol/l.Patient 6: serum free t4 result = >64.4 pmol/l; repeat serum post re-centrifugation = 29.2 pmol/l; plasma (edta) free t4 result = 9.8 pmol/l.It was noted that this patient was prescribed levothyroxine where the plasma result pointed towards insufficient thyroxine replacement.There was no further impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information from the article ¿misleading thyroid function tests in congenital dysfibrinogenemia¿, a ticket trending review, a device history record review, a technical review, and a labeling review.Return testing was not completed as returns were not available.The data and information provided in the article were reviewed and support the complaint issue.A ticket search by lot could not be performed as the likely cause lot is unknown.A review of tracking and trending data for the architect free t4 assay did identify an increase in complaints.A review of the device history record did not identify any non-conformances or deviations with the likely cause list number and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.A technical review of the article was performed.The article reports inconsistent results from abbott thyroid function test (tft) assays, including tsh, ft4, and tt3, in patients diagnosed with congenital dysfibrinogenemia (cd).Cd is a rare coagulation disorder that impairs fibrinogen function, leading to defective clot formation and the presence of latent fibrin in the sample.This latent fibrin remains in the sample and can interfere with the accuracy of the abbott tft assays.The abbott tft assays' package insert instructs that the presence of fibrin can cause interference, potentially leading to inaccurate or inconsistent results.The ifu also highlights that some specimens may exhibit increased clotting time.If the specimen is centrifuged before a complete clot forms the presence of fibrin may cause erroneous results.The package insert also advises that test results should be interpreted in conjunction with other clinical data, such as symptoms and additional test results.Based on this investigation, no systemic issue or deficiency was identified with the architect free t4 reagent, lot number unknown.

• Brand Name: ARCHITECT FREE T4 REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20978643
• Report Number: 3005094123-2024-00653
• Device Sequence Number: 18233104
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07K65-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, 117UNKNOWND11; ARC I1000SR MOD, 01L86-01, 117UNKNOWND11
• Patient Age: 89 YR
• Patient Sex: Female