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

Catalog Number 07K65-29

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2024

Event Type  malfunction  

Manufacturer Narrative

Section a1 - patient identifier complete entry = (b)(6).An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated architect free t4 results generated for a patient that is on anticoagulants.The following data was provided (customer¿s reference range >0.70 to 1.48 ng/dl): sample id (b)(6) initial result = 1.65 ng/dl (the same as last year), repeat = 0.75 ng/dl no impact to patient management was reported.

Event Description

The customer observed falsely elevated architect free t4 results generated for a patient that is on anticoagulants.The following data was provided (customer¿s reference range >0.70 to 1.48 ng/dl): sample id (b)(6)initial result = 1.65 ng/dl (the same as last year), repeat = 0.75 ng/dl no impact to patient management was reported.

Manufacturer Narrative

Update to sections d4 - expiration date, d4 - primary udi number, and h4 - device mfg date 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 of a retained reagent kit.Return testing was not completed, as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot identified elevated complaint activity; however, no trends regarding commonalities for complaint lot number and issue were identified.Device history record review did not identify any non-conformances, potential non-conformances, or deviations for the likely cause list number and complaint issue.Retained analysis of architect free t4 of the complaint lot was performed.All specifications were met, indicating that the lot generates the expected results and is performing acceptably.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect free t4, lot 56026ud00, was identified.

• Brand Name: ARCHITECT FREE T4 REAGENT KIT
• Type of Device: 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: 19003485
• MDR Text Key: 338982419
• Report Number: 3005094123-2024-00146
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)240918(10)56026UD00
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K65-29
• Device Lot Number: 56026UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)