MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division Alinity I Free T4 Reagent Kit; Radioimmunoassay, free thyroxine

Catalog Number	07P70-20
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant results for multiple assays generated by the alinity i processing module for a 36-year-old female patient.These results were inconsistent with those obtained on the roche and beckman platforms and were not aligned with the patient¿s clinical presentation.The following data were provided: alinity i total ¿-hcg: sample id (b)(6) : (b)(6)2026 alinity initial result = 93.43 miu/ml (positive), repeat result = 80.24 miu/ml (positive) external laboratory (roche) = 0.200 iu/l (negative).(b)(6)2026 sample id: (b)(6) (new draw) alinity result = 93.08 miu/ml (positive) external laboratory (beckman) result = 0.14 miu/ml.The patient underwent an ultrasound examination, which was negative for pregnancy.Mounjaro therapy was discontinued when pregnancy was suspected following the positive ¿-hcg result and restarted at the end of (b)(6) 2026.Alinity i tsh (reference range: 0.35 to 4.94 ¿iu/ml) sample id (b)(6) : (b)(6)2026 alinity initial result = 18.1427 miu/ml, repeat result = 19.24 miu/ml external laboratory (roche)= 0.005 µiu/ml.(b)(6)2026 sample id: (b)(6) (new draw) alinity result = 18.0864 miu/ml external laboratory (beckman) result = 0.60 µiu/ml.Historical results for tsh: (b)(6) 2025 tsh result = 1.04 mu/l (b)(6)r 2025 tsh result = 47.69 miu/l.Alinity i free t4 (reference range: 9.01 to 19.05 pmol/l) sample id (b)(6) : (b)(6)2026 alinity initial result = 18.25 pmol/l, repeat result = 25.98 pmol/l external laboratory (roche)= 29.5 pmol/l.(b)(6)2026 sample id: (b)(6) (new draw) alinity result = 17.66 pmol/l external laboratory (beckman) result = 1.70 ng/dl.Alinity i prolactin (reference range for female: 5.18 to 26.53 ng/ml) sample id (b)(6) : (b)(6)2026 alinity initial result = 50.15 ng/ml, repeat result = 43.96 ng/ml external laboratory (roche)= 21.4 ng/ml.(b)(6)2026 sample id:(b)(6) (new draw) alinity result = 45.79 ng/ml external laboratory (beckman) result = 40.23 ng/ml.Medical history: gastric sleeve surgery (2014 and 2021) obesity history of prediabetes amenorrhea for approximately one year.The patient was diagnosed with hypothyroidism in (b)(6) 2026 due to persistently elevated tsh results.A recent thyroid ultrasound showed no significant abnormalities.Tsh results remained elevated on the alinity platform despite multiple thyroxine dose adjustments.Thyroxine therapy started on (b)(6)2026 at 50 mcg/day and repeated dose escalation up to 300 mcg/day due to persistently elevated tsh results.Pituitary mri findings were reported as normal.There was no patient harm reported.Anti-tpo and anti-tg antibodies were negative.No further impact to patient management was reported.Update: on (b)(6)2026, the customer provided additional information.The patient sample underwent additional testing using peg 6000 (polyethylene glycol 6000) precipitation to investigate potential sample-specific interference.Following peg treatment, the tsh result was 1.4055 miu/l and the total ¿-hcg result was <4.60 miu/ml (negative).
Additional Manufacturer Narrative
Section b5 - describe event or problem: this section was updated with additional information.Section h6: medical device problem code: this was corrected from a090813 to a090809.Section h6 - health effect - impact code: this was corrected from f26 to f10.The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify an increase in complaints for the alinity i free t4 assay (list number 07p70); however, no trends were identified for lot 86120ud00.The overall performance of the alinity i free t4 reagents in the field was reviewed using worldwide data.The review shows that the result for the median population for lot number 86120ud00 is within established limits, indicating the reagent lot is performing acceptably in the field.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 86120ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 86120ud00.

• Brand Name: Alinity I 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 ; +49()6122582960
• MDR Report Key: 50763362
• Report Number: 3005094123-2026-00455
• Device Sequence Number: 9224770
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)270316(10)86120UD00
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 07P70-20
• Device Lot Number: 86120UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2026
• 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, (b)(6)
• Patient Age: 36 YR
• Patient Sex: Female