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

Catalog Number	07K65-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for one sample.The following result were provided: initial result >5.0 ng/dl, repeat results 1.7 ng/dl, 1.36 ng/dl, repeat result on another architect (b)(6) 1.40 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
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, labeling review, device history record review, and in house testing.Review of all the information provided by the customer was reviewed.Return testing was not performed as returns were not available.There was an increase in complaint activity, however, no related trends were identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not show any nonconformances, potential nonconformances, or deviations associated with the likely cause list number and complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot number 56001ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for one sample.The following result were provided: initial result >5.0 ng/dl, repeat results 1.7 ng/dl, 1.36 ng/dl, repeat result on another architect ((b)(6)) 1.40 ng/dl no impact to patient management was reported.

• 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: 19096116
• Report Number: 3005094123-2024-00183
• Device Sequence Number: 7344404
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)240926(10)56001UD00
• 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): 04/30/2024

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: 07K65-34
• Device Lot Number: 56001UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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