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

Catalog Number 07P70-30

Device Problem High Test Results (2457)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

A1 patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated alinity i free t4 and provided the following data for sample id (b)(6): on (b)(6) 2024, initial result from serum sample on sn: (b)(6) was >5 ng/dl.Repeated on sn (b)(6), which generated a result of 1.39 ng/dl.A plasma sample from the same patient was also tested on sn (b)(6), which generated a result of 1.26 ng/dl.The serum sample was then retested on sn: (b)(6), which generated a result of 1.40 ng/dl.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

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.Return testing was not completed as specimens were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any issues associated with the complaint lot and customer reported issue.Ticket search by lot identified lot 56159ud00 did identify an increase in complaint activity, however the review of ticket and trending did not identify any trends regarding commonalities for complaint lot and customer reported issue.Additionally, in-house testing was conducted for complaint lot 56159ud00, which concluded all criteria were met for controls, indicating that the lot is performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity i free t4 result reagent lot: 56159ud00.

Event Description

The customer reported falsely elevated alinity i free t4 and provided the following data for sample id (b)(6) : on (b)(6) 2024, initial result from serum sample on sn:(b)(6) was >5 ng/dl.Repeated on sn (b)(6) , which generated a result of 1.39 ng/dl.A plasma sample from the same patient was also tested on sn (b)(6) , which generated a result of 1.26 ng/dl.The serum sample was then retested on sn: (b)(6) , which generated a result of 1.40 ng/dl.Per the customer the discrepant results were not reported out to the patient¿s medical provider.

• Brand Name: ALINITY I 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: 18712676
• MDR Text Key: 335810055
• Report Number: 3005094123-2024-00064
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07P70-30
• Device Lot Number: 56159UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6). ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).