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

Catalog Number	07K65-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect free t4 results generated on the arhcitect i2000sr analyzer.The customer retests the free t4 result when it exceeds the upper limit.The customer says it often occurs in outpatients.The following data was provided: on (b)(6) 2024: sample id (b)(6): initial result = 2.15 ng/dl; repeat result = 1.57 ng/dl sample id (b)(6): initial result = 1.68 ng/dl; repeat result = 1.38 ng/dl on (b)(6)2024: sample id (b)(6): initial result = 1.84 ng/dl; repeat result = 1.58 ng/dl sample id (b)(6): initial result = 1.64 ng/dl; repeat result = 1.24 ng/dl sample id (b)(6): initial result = 1.60 ng/dl; repeat result = 1.21 ng/dl 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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated architect free t4 results generated on the arhcitect i2000sr analyzer.The customer retests the free t4 result when it exceeds the upper limit.The customer says it often occurs in outpatients.The following data was provided: on (b)(6) 2024: sample id (b)(6): initial result = 2.15 ng/dl; repeat result = 1.57 ng/dl; sample id (b)(6): initial result = 1.68 ng/dl; repeat result = 1.38 ng/dl.On (b)(6) 2024: sample id (b)(6): initial result = 1.84 ng/dl; repeat result = 1.58 ng/dl; sample id (b)(6): initial result = 1.64 ng/dl; repeat result = 1.24 ng/dl; sample id (b)(6): initial result = 1.60 ng/dl; repeat result = 1.21 ng/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
After review of this submission, it was discovered section a1 - patient identifier needed to be updated to document the multiple sample ids noted in section b5.Correction to section a1 updated to multiple and include here the complete sample ids: (b)(6); (total of 5 different patients).The complaint investigation for falsely elevated architect free t4 results included a search for similar complaints, and the review of complaint text, trending data, labeling, and in-house testing.Return testing was not performed 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 search for similar complaints did identify an increase in complaint activity for lot 56001ud00, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, in-house performance testing was completed which indicates the product is performing as expected.A review of device history record did not identify any non-conformances or deviations associated with the list number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect free t4 reagent lot 56001ud00.

• 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: 19203550
• Report Number: 3005094123-2024-00213
• Device Sequence Number: 8034689
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)240923(10)56001UD00
• 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
• Report Date (Section B): 05/06/2024

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: 09/23/2024
• Device Catalogue Number: 07K65-34
• Device Lot Number: 56001UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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); ARC I2K PROC MOD,03M74-01, (B)(6)
• Patient Sex: Unknown