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

Catalog Number 07K65-39

Device Problem High Test Results (2457)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

Completed information for sections a1 patient identifier and a2 age at time of event/age units: sid (b)(6) for 65 year old and sid (b)(6) for 86 year old 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 reported falsely elevated architect free t4 results on two patients that were not reported out of the lab.The following results were provided (customer provided reference range: 0.70 to 1.48 ng/ml): 65 year old: sid (b)(6) , initial result = 2.89 ng/dl, repeats = 1.58 ng/dl and 1.40 ng/ml additional laboratory data was provided: tsh = 2.08 uiu/ml 86 year old: sid (b)(6) , initial result = 3.70 ng/dl, repeats = 2.13 ng/dl, 1.48 ng/dl, and 1.32 ng/dl additional laboratory data was provided: tsh = 1.94 uiu/ml there was no impact to patient management reported.

Event Description

The customer reported falsely elevated architect free t4 results on two patients that were not reported out of the lab.The following results were provided (customer provided reference range: 0.70 to 1.48 ng/ml): 65 year old: sid (b)(6) initial result = 2.89 ng/dl, repeats = 1.58 ng/dl and 1.40 ng/ml additional laboratory data was provided: tsh = 2.08 uiu/ml.86 year old: sid (b)(6) initial result = 3.70 ng/dl, repeats = 2.13 ng/dl, 1.48 ng/dl, and 1.32 ng/dl additional laboratory data was provided: tsh = 1.94 uiu/ml.There was no impact to patient management reported.

Manufacturer Narrative

Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 56001ud01 and 56001ud, however, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not identify any non-conformances, potential non-conformances, or deviations associated with lot 56001ud01 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the architect free t4 for reagent for lot 56001ud01 was identified.

• 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: 19180972
• MDR Text Key: 341240767
• Report Number: 3005094123-2024-00203
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119812
• UDI-Public: (01)00380740119812(17)240926(10)56001UD01
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/19/2024

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: 07K65-39
• Device Lot Number: 56001UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 06/17/2024
• Supplement Dates FDA Received: 06/19/2024
• 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 I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)