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

Catalog Number 07P70-20

Device Problem High Test Results (2457)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i free t4 results for three patients.The following data was provided (normal reference range 0.6-1.8 ng/dl): (b)(6) 2024 sid (b)(6) initial result 2.6 ng/dl, repeated 1.2 / 0.91 / 1.86 / 0.96 / 1.95 ng/dl (b)(6) 2024 sid unk initial result 2.09 ng/dl, repeated 1.02 ng/dl.(b)(6) 2024 sid (b)(6) initial result >5 ng/dl, repeated 1.0 ng/dl.(b)(6) 2024 sid (b)(6) initial result 2.45 ng/dl, repeat on another analyzer resulted 1.62 ng/dl, (b)(6) 2024 sid (b)(6) initial result 2.23 ng/dl, repeat 1.37 ng/dl.No impact to patient management was reported.

Manufacturer Narrative

This issue was previously reported under mdr number 3016438761-2024-00109-00 under a different suspect device.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

A review of customer data aligned with customer¿s issue and no additional issues were identified.An increase in complaints has been observed for lot 53312ud04, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any non-conformances or deviations with the list number and complaint issue.In-house performance testing was completed which indicates the product is performing as expected.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 assay was identified.

• 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: 19166635
• MDR Text Key: 341014395
• Report Number: 3005094123-2024-00194
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)240524(10)53312UD04
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Expiration Date: 05/24/2024
• Device Catalogue Number: 07P70-20
• Device Lot Number: 53312UD04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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)