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 03/01/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated architect free t4 results for multiple samples.The following data was provided: 01mar2024 sid (b)(6)initial result = 1.51 ng/dl, repeat = 1.06 ng/dl 01mar2024 sid (b)(6)initial result = 1.75 ng/dl, repeat = 1.15 ng/dl 01mar2024 sid (b)(6)initial result = 2.13 ng/dl, repeat = 1.47 ng/dl no impact to patient management was reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: sids (b)(6), (b)(6), (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect free t4 results for multiple samples.The following data was provided: (b)(6) 2024 sid (b)(6) initial result = 1.51 ng/dl, repeat = 1.06 ng/dl.(b)(6) 2024 sid (b)(6) initial result = 1.75 ng/dl, repeat = 1.15 ng/dl.(b)(6) 2024 sid (b)(6) initial result = 2.13 ng/dl, repeat = 1.47 ng/dl.No impact to patient management was reported.

Manufacturer Narrative

Section d4 primary udi number was updated from (b)(4) to (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Additionally, in-house testing was completed.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 not identify an increase in complaint activity for lot 53468ud00.Ticket trending review did not identify any trends regarding commonalities for lot number 53468ud00 and issue.In-house performance testing was completed which indicates the product is performing as expected.Device history record review did not identify any non-conformances or deviations associated with lot 53468ud00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 reagent lot 53468ud00 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: 18937746
• MDR Text Key: 338068285
• Report Number: 3005094123-2024-00133
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: 00380740119799
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 53468UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, (B)(6).; ARC I1000SR MOD, 01L86-01, (B)(6).