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 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated alinity i free t4 results for multiple samples.The following example result was provided: (customer provided normal range 0.8-1.9 ng/dl).Original result= >5ng/dl, repeated on same instrument =0.9 ng/dl no impact to patient management was reported.

Event Description

The customer observed falsely elevated alinity i free t4 results for multiple samples.The following example result was provided: (customer provided normal range 0.8-1.9 ng/dl).Original result= >5ng/dl, repeated on same instrument =0.9 ng/dl no impact to patient management was reported.

Manufacturer Narrative

Updated information in section d4 primary udi number.The complaint investigation for falsely elevated alinity i free t4 results 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.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not performed as returns were not available.An increase in complaints has been observed for lot 54471ud00, however, in-house performance was completed which indicates the product is performing as expected.The device history record review did not show any nonconformances, potential nonconformances, or deviations associated with the likely cause list number and complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot number 54471ud00 was identified.All available patient information was included.Additional patient details are not available.

• 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: 18873629
• MDR Text Key: 337301001
• Report Number: 3005094123-2024-00103
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)240718(10)54471UD00
• 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 Catalogue Number: 07P70-20
• Device Lot Number: 54471UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2023
• 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)