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

Catalog Number 07P70-77

Device Problem High Test Results (2457)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

The customer reported falsely elevated alinity i free t4 (ft4) results for 3 samples.The customer¿s reference range for free t4 is 0.7-1.48 ng/dl.The following data was provided: sample 1: initial result = 1.53 ng/dl; repeat result = 1.36 ng/dl.Sample 2: initial result = 1.70 ng/dl; repeat result = 1.44 ng/dl.Sample 3: initial result = 1.49 ng/dl; repeat result = 1.22 ng/dl.There was no impact to patient management reported.

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.

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 returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.An increase in complaints has been observed for lot 57607ud02.A review of tracking and trending for list number 07p70 did identify a related trend regarding commonalities for the complaint lot and issue.However, in-house testing was performed using retained reagent samples of lot 57607ud00 of which 57607ud02 is a sublot containing the same components.Testing met acceptance criteria and the product is performing as expected.A review of the device history record did not identify any 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 was identified for alinity i free t4 reagent lot 57607ud02.

Event Description

The customer reported falsely elevated alinity i free t4 (ft4) results for 3 samples.The customer¿s reference range for free t4 is 0.7-1.48 ng/dl.The following data was provided: sample 1: initial result = 1.53 ng/dl; repeat result = 1.36 ng/dl sample 2: initial result = 1.70 ng/dl; repeat result = 1.44 ng/dl sample 3: initial result = 1.49 ng/dl; repeat result = 1.22 ng/dl there was no impact to patient management reported.

Event Description

The customer reported falsely elevated alinity i free t4 (ft4) results for 3 samples.The customer¿s reference range for free t4 is 0.7-1.48 ng/dl.The following data was provided: sample 1: initial result = 1.53 ng/dl; repeat result = 1.36 ng/dl; sample 2: initial result = 1.70 ng/dl; repeat result = 1.44 ng/dl; sample 3: initial result = 1.49 ng/dl; repeat result = 1.22 ng/dl.There was no impact to patient management reported.

• 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: 19067507
• MDR Text Key: 340473264
• Report Number: 3005094123-2024-00174
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173715
• UDI-Public: (01)00380740173715(17)241031(10)57607UD02
• 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,Followup
• Report Date: 05/03/2024

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: 07P70-77
• Device Lot Number: 57607UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/11/2024
• Supplement Dates FDA Received: 05/03/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)