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

Catalog Number	07K65-39
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005094123-2024-00203
• Device Sequence Number: 20641059
• Product Code: CEC
• UDI-Device Identifier: 00380740119812
• UDI-Public: (01)00380740119812(17)240926(10)56001UD01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2024
• Device Catalogue Number: 07K65-39
• Device Lot Number: 56001UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown