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 02/19/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for a 76-year-old female patient.The results did not match the patient¿s previous result.The same sample was repeated multiple times and lower results were obtained.The following data was provided: customer¿s reference range: 9.01 to 19.50 pmol/l.Initial result = >64.35pmol/l.Same sample repeated 1 hour later = 47.09 pmol/l.Same sample repeated 2 hour later = 36.40 pmol/l.Same sample repeated 3 hour later = 34.34 pmol/l.Same sample repeated 5 hour later = 21.67 pmol/l.Patient¿s previous result from (b)(6) 2024 = 10.68 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.

Manufacturer Narrative

Section d4 - primary udi number: this section was corrected from (b)(4).The complaint investigation for falsely elevated architect free t4 results 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.A search for similar complaints did identify an increase in complaint activity for lot 56001ud02, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, 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 56001ud02 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 56001ud02.

Event Description

The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for a 76-year-old female patient.The results did not match the patient¿s previous result.The same sample was repeated multiple times and lower results were obtained.The following data was provided: customer¿s reference range: 9.01 to 19.50 pmol/l.Initial result = >64.35pmol/l same sample repeated 1 hour later = 47.09 pmol/l.Same sample repeated 2 hour later = 36.40 pmol/l.Same sample repeated 3 hour later = 34.34 pmol/l.Same sample repeated 5 hour later = 21.67 pmol/l.Patient¿s previous result from (b)(6) 2024 = 10.68 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: 18856068
• MDR Text Key: 337109126
• Report Number: 3005094123-2024-00096
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173678
• UDI-Public: (01)00380740173678(17)240926(10)56001UD02
• 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: 05/08/2024

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: 56001UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• 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)
• Patient Age: 76 YR
• Patient Sex: Female