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

Catalog Number	07K65-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier: complete list of sample ids are (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated architect free t4.The customer also reported that the controls tend to be high as well.The customer provided the following example data on (b)(6) 2024: reference value: 0.70-1.48 ng/dl: sample id (b)(6) initial result was 1.50 and repeat results were 1.30 & 1.24.Sample id (b)(6) initial result was 1.53 and repeat results were 1.16 & 1.07.Sample id (b)(6) initial result was 1.70 and repeat results were 1.35 & 1.39.Additional laboratory data provided: sample id (b)(6) tsh was 2.5071 uiu/ml, free t3 was 2.68 pg/ml.Sample id (b)(6) tsh was 1.4070 uiu/ml.Sample id (b)(6) tsh was 0.0305 uiu/ml, free t3 was 3.83 pg/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did identify an increase in complaints for the architect free t4 reagent and for the complaint lot 61281ud00.However, in-house testing was completed which concluded the complaint lot met acceptance criteria, demonstrating that the lot is performing as expected.Device history review did not identify any issues with the complaint lot.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 reagent, lot 61281ud00 was identified.
Event or Problem Description
The customer reported falsely elevated architect free t4.The customer also reported that the controls tend to be high as well.The customer provided the following example data on (b)(6) 2024: reference value: 0.70-1.48 ng/dl sample id (b)(6), initial result was 1.50 and repeat results were 1.30 & 1.24.Sample id (b)(6), initial result was 1.53 and repeat results were 1.16 & 1.07.Sample id (b)(6), initial result was 1.70 and repeat results were 1.35 & 1.39.Additional laboratory data provided: sample id (b)(6), tsh was 2.5071 uiu/ml, free t3 was 2.68 pg/ml sample id (b)(6), tsh was 1.4070 uiu/ml sample id (b)(6), tsh was 0.0305 uiu/ml, free t3 was 3.83 pg/ml there was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect free t4.The customer also reported that the controls tend to be high as well.The customer provided the following example data on (b)(6) 2024: reference value: 0.70-1.48 ng/dl sample id (b)(6), initial result was 1.50 and repeat results were 1.30 & 1.24, sample id (b)(6), initial result was 1.53 and repeat results were 1.16 & 1.07, sample id (b)(6), initial result was 1.70 and repeat results were 1.35 & 1.39.Additional laboratory data provided: sample id (b)(6), tsh was 2.5071 uiu/ml, free t3 was 2.68 pg/ml sample id (b)(6), tsh was 1.4070 uiu/ml sample id (b)(6), tsh was 0.0305 uiu/ml, free t3 was 3.83 pg/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
Section h6 imdrf coding for annex d was corrected.

• 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: 20885294
• Report Number: 3005094123-2024-00636
• Device Sequence Number: 9043916
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)250219(10)61281UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Expiration Date: 02/19/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 61281UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 02/18/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/14/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown