MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07P48-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A literature article by ingo mrosewski, viola dannheim, robert klett, matthias urbank, silvia stobbe, jochen r ittner and martin bidlingmaier, ¿rare coincidence: macro-thyroid-stimulating hormone and multiple manufacturer-specific interferences in thyroid hormone immunoassays¿ annals of clinical biochemistry 2024, vol 61(6) 484-489, documented falsely elevated alinity i tsh results for a 44-year-old male patient with no signs of thyroid disease and no personal or family history of thyroid dysfunction.The following data was provided: initial work-up in january 2023 generated by non-abbott device: roche e801 tsh result = 63.9 miu/l (reference range: 0.40 to 4.00 miu/l) siemens advia centaur xpt tsh result = 8.89 miu/l (reference range: 0.35 to 5.50 miu/l siemens dimension exl tsh result = 53.2 miu/l (reference range: 0.36 to 3.74 miu/l) siemens immulite 2000 tsh result = 57.1 miu/l (reference range: 0.40 to 4.00 miu/l) beckman coulter/brahms tsh result = 10.3 miu/l (reference range: 0.45 to 4.50 miu/l).Work-up 8 weeks later: alinity i tsh result = 35.4 miu/l (reference range: 0.35 to 4.94 miu/l) alinity i tsh result after hbt (heterophile blocking tube) = 35.8 miu/l alinity i tsh result after nabt (non-specific antibody blocking tube) = 32.7 miu/l roche e801 tsh result = 56.0 miu/l roche e801 tsh result after peg (polyethylene glycol) = 1.38 miu/l roche e801 tsh result after ba (biotin absorption) = 55.3 miu/l final patient follow-up in (b)(6) 2024: roche e801 tsh result = 73.8 miu/l there was no impact to patient management reported.
Additional Manufacturer Narrative
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 ingo mrosewski, viola dannheim, robert klett, matthias urbank, silvia stobbe, jochen r ittner and martin bidlingmaier, ¿rare coincidence: macro-thyroid-stimulating hormone and multiple manufacturer-specific interferences in thyroid hormone immunoassays¿ annals of clinical biochemistry 2024, vol 61(6) 484-489, documented falsely elevated alinity i tsh results for a 44-year-old male patient with no signs of thyroid disease and no personal or family history of thyroid dysfunction.The following data was provided: initial work-up in january 2023 generated by non-abbott device: roche e801 tsh result = 63.9 miu/l (reference range: 0.40 to 4.00 miu/l), siemens advia centaur xpt tsh result = 8.89 miu/l (reference range: 0.35 to 5.50 miu/l, siemens dimension exl tsh result = 53.2 miu/l (reference range: 0.36 to 3.74 miu/l), siemens immulite 2000 tsh result = 57.1 miu/l (reference range: 0.40 to 4.00 miu/l), beckman coulter/brahms tsh result = 10.3 miu/l (reference range: 0.45 to 4.50 miu/l).Work-up 8 weeks later: alinity i tsh result = 35.4 miu/l (reference range: 0.35 to 4.94 miu/l), alinity i tsh result after hbt (heterophile blocking tube) = 35.8 miu/l, alinity i tsh result after nabt (non-specific antibody blocking tube) = 32.7 miu/l, roche e801 tsh result = 56.0 miu/l, roche e801 tsh result after peg (polyethylene glycol) = 1.38 miu/l, roche e801 tsh result after ba (biotin absorption) = 55.3 miu/l.Final patient follow-up in march 2024: roche e801 tsh result = 73.8 miu/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information from the article ¿rare coincidence: macro-thyroid-stimulating hormone and multiple manufacturer-specific interferences in thyroid hormone immunoassays¿, a ticket trending review, a device history record 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 alinity i tsh assay did not identify an increase in complaints.A review of the device history record did not identify any non-conformance's 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.Based on this investigation, no systemic issue or deficiency was identified with the alinity i tsh reagent, lot number unknown.

• Brand Name: ALINITY I TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 20978930
• Report Number: 3005094123-2024-00654
• Device Sequence Number: 20948019
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983442
• 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): 03/04/2025

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: 07P48-20
• 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: 02/25/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/04/2025
• 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: ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11.; ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11.
• Patient Age: 44 YR
• Patient Sex: Male