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

Catalog Number 07K65-78

Device Problem High Test Results (2457)

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

Event Date 04/12/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect free t4 results for one patient.The sample was repeated with lower results.The following data was provided: initial result processed on (b)(6) 2024 = 29.77 repeat results = 16.04 and 17.43.Reference range = 8.5-19.04 pmol/l no impact to patient management was reported.

Event Description

The customer observed falsely elevated architect free t4 results for one patient.The sample was repeated with lower results.The following data was provided: initial result processed on 12apr2024 = 29.77 repeat results = 16.04 and 17.43 reference range = 8.5-19.04 pmol/l no impact to patient management was reported.

Manufacturer Narrative

Likely cause size code and lot number were updated on 29may2024 from 07k65-78 lot 57269ud00 to 07k65-77 lot 57269ud02.Section d4 was updated including catalog #, lot #, and primary udi number.The complaint investigation for falsely elevated architect free t4 result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In addition, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 57269ud02, however, in-house performance testing was completed which indicates the product is performing as expected.A review of the device history record did not identify any non-conformances or deviations with lot number 57269ud02 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect free t4 reagent, lot number 57269ud02.

• 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: 19165499
• MDR Text Key: 341015406
• Report Number: 3005094123-2024-00193
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173685
• UDI-Public: (01)00380740173685(17)241016(10)57269UD00
• 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: 04/23/2024

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: 07K65-78
• Device Lot Number: 57269UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2023
• 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)