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

Catalog Number 07K65-77

Device Problem High Test Results (2457)

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

Event Date 01/29/2024

Event Type  malfunction  

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 = see section b5.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated architect free t4 results for numerous patients.The sample ids provided ranged from (b)(6) to (b)(6) with initial results, on (b)(6) 2024, ranging from 19.08 to >64.35 and repeat results ranging from 9.63 to 23.64 pmol/l, customer¿s normal range is 9.01-19.05 pmol/l.There was no impact to patient management reported.

Manufacturer Narrative

Updated section d4 - primary udi number from (b)(4).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 53725ud02, stored at the recommended storage condition.The testing was completed indicating that the product is performing as expected.A search for similar complaints did identify an increase in complaint activity for lot 53725ud02, however, no related trends were identified regarding commonalities for complaint lot number and issue.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 53725ud02, was identified.

Event Description

The customer observed falsely elevated architect free t4 results for numerous patients.The sample ids provided ranged from (b)(6) with initial results, on (b)(6) 2024, ranging from 19.08 to >64.35 and repeat results ranging from 9.63 to 23.64 pmol/l, customer¿s normal range is 9.01-19.05 pmol/l.There was no impact to patient management reported.

• Brand Name: ARCHITECT 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: 18790361
• MDR Text Key: 336507587
• Report Number: 3005094123-2024-00080
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173678
• UDI-Public: (01)00380740173678(17)240629(10)53725UD02
• 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
• Report Date: 05/07/2024

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: 07K65-77
• Device Lot Number: 53725UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)