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

Catalog Number 07K65-77

Device Problem Low Test Results (2458)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

The customer reported falsely decreased architect free t4 (ft4) results on a 14-year-old female patient with the clinical diagnosis of irregular menstruation.The results were not reported out of the lab.The following results were provided: (b)(6) 2024- ft4 initial results = 0.82 ng/dl, repeat results=0.95 ng/dl (reference range ¿ 0.89-1.37 mg/dl).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.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history review, in-house testing and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.The search for similar complaints by lot 51653ud02 did not identify an increase in complaint activity for the issue.The ticket trending review of complaint data did not identify any related trend regarding commonalities for complaint lot number 51653ud02 and issue.A device history review did not identify any nonconformances, potential nonconformances or deviations associated with the lot number 51653ud02 and complaint issue.In house testing of retained lot number 51653ud01 met acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic or deficiency of the architect free t4 lot 51653ud02 was identified.

Event Description

The customer reported falsely decreased architect free t4 (ft4) results on a 14-year-old female patient with the clinical diagnosis of irregular menstruation.The results were not reported out of the lab.The following results were provided: ft4 initial results = 0.82 ng/dl, repeat results=0.95 ng/dl (reference range ¿ 0.89-1.37 mg/dl).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: 19004654
• MDR Text Key: 338982137
• Report Number: 3005094123-2024-00148
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173678
• UDI-Public: (01)00380740173678(17)240504(10)51653UD02
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 51653UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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, ISR62187; ARC I2000SR INST, 03M74-02, ISR62187
• Patient Age: 14 YR
• Patient Sex: Female