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

Catalog Number 07P70-20

Device Problem High Test Results (2457)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated alinity i free t4 (ft4) results which does not match with clinical picture for multiple patients.The result provided were: on 26feb2024 patient 1: sid (b)(6) initial = 22.94 pmol/l /repeated=13.15 pmol/l additional information provided: ft3=3.65 pmol/l; tsh=3.147 uiu/ml patient 2: initial=19.54 pmol/l /repeated on 27feb2024=11.90 pmol/l and 11.73 pmol/l on 14mar2024 53yrs old male patient initial=20.37 pmol/l /repeated=14.82 pmol/l additional information provided: tsh=2.816 miu/ml laboratory reference range for ft4= 9.0 to 19.0 pmol/l there was no reported impact to patient management.

• Brand Name: ALINITY I 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: 18913759
• MDR Text Key: 337777987
• Report Number: 3005094123-2024-00122
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: 00380740121815
• Combination Product (y/n): N
• Reporter Country Code: BK
• 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: 03/15/2024

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: 07P70-20
• Device Lot Number: 57272UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1