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

Catalog Number 07K65-77

Device Problem High Test Results (2457)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated architect free t4 result for one patient sample when comparing the initial result to the retest result.The following data was provided (reference range: 9.01-19.05 pmol/l or 0.70-1.48 ng/dl): initial free t4 result = > 64 pmol/l (> 5.00 ng/dl) repeat free t4 result after centrifugation = 19.05 pmol/l (1.48 ng/dl) there was no impact to patient management reported.

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 was performed on lot 53725ud02.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 search for similar complaints did identify an increase in complaint activity for lot 53725ud02, 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 the device history record did not identify any potential non-conformances, non-conformances, or deviations associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect free t4 reagent lot 53725ud02 was identified.

Event Description

The customer reported a falsely elevated architect free t4 result for one patient sample when comparing the initial result to the retest result.The following data was provided (reference range: 9.01-19.05 pmol/l or 0.70-1.48 ng/dl): initial free t4 result = > 64 pmol/l (> 5.00 ng/dl); repeat free t4 result after centrifugation = 19.05 pmol/l (1.48 ng/dl).There was no impact to patient management reported.

• 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: 18980208
• MDR Text Key: 338620948
• Report Number: 3005094123-2024-00140
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173678
• UDI-Public: (01)00380740173678(17)240629(10)53725UD02
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K65-77
• Device Lot Number: 53725UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)