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 03/20/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i free t4 results for several patients.The following data was provided (customer¿s normal range is 9.01-19.05 pmol/l): sample 1 initial result was 21.07, repeat result was 13.99 pmol/l, sample 2 initial result was 19.83, repeat result was 13.79 pmol/l, sample 3 initial result was 22.58, repeat result was 18.99 pmol/l, sample 4 initial result was 20.24, repeat result was 14.62 pmol/l, sample 5 initial result was 25.85, repeat result was 18.67 pmol/l, sample 6 initial result was 20.03, repeat result was 15.93 pmol/l, sample 7 initial result was 19.25, repeat result was 17.58 pmol/l.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1: patient identifier complete entry = sample 1, sample 2, sample 3, sample 4, sample 5, sample 6, and sample 7.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation for a falsely elevated alinity i free t4 results included a search for similar complaints, the review of complaint text, trending data, labeling, device history records, and testing of retained reagent kit.Return testing was not completed, as returns were not available.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 56201ud00, which is a sublot of the same product reagent lot 56201ud02, stored at the recommended storage condition.The testing was completed indicating that the product is performing as expected.An increase in complaints has been observed for lot 56201ud02, however, 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 for the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i free t4, lot number 56201ud02, was identified.

Event Description

The customer observed falsely elevated alinity i free t4 results for five patients.The following data was provided (customer¿s normal range is 9.01-19.05 pmol/l): sample 1 initial result was 21.07, repeat result was 13.99 pmol/l.Sample 2 initial result was 19.83, repeat result was 13.79 pmol/l.Sample 3 initial result was 22.58, repeat result was 18.99 pmol/l.Sample 4 initial result was 20.24, repeat result was 14.62 pmol/l.Sample 5 initial result was 25.85, repeat result was 18.67 pmol/l.Sample 6 initial result was 20.03, repeat result was 15.93 pmol/l.Sample 7 initial result was 19.25, repeat result was 17.58 pmol/l.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: 19053502
• MDR Text Key: 339788509
• Report Number: 3005094123-2024-00169
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173715
• UDI-Public: (01)00380740173715(17)240831(10)56201UD02
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• 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: 56201UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2023
• 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, AI22840; ALNTY I PROCESSING MODU, 03R65-01, AI22840