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

Catalog Number 07K65-34

Device Problem High Test Results (2457)

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

Event Date 04/02/2024

Event Type  malfunction  

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 Description

The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for one sample.The following result were provided: initial result >5.0 ng/dl, repeat results 1.7 ng/dl, 1.36 ng/dl, repeat result on another architect (b)(6) 1.40 ng/dl.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect free t4 results 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.Review of all the information provided by the customer was reviewed.Return testing was not performed as returns were not available.There was an increase in complaint activity, however, no related trends were identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not show any nonconformances, potential nonconformances, or deviations associated with the likely cause list number and complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot number 56001ud00 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for one sample.The following result were provided: initial result >5.0 ng/dl, repeat results 1.7 ng/dl, 1.36 ng/dl, repeat result on another architect ((b)(6)) 1.40 ng/dl no impact to patient management was 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: 19096116
• MDR Text Key: 340686499
• Report Number: 3005094123-2024-00183
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)240926(10)56001UD00
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K65-34
• Device Lot Number: 56001UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• 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)