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

Catalog Number 07P70-30

Device Problem High Test Results (2457)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated alinity i free t4 results for patient samples.The following information was provided (customer¿s reference range 9-19 pmol/l): sample id (b)(6) initial = 19.55 pmol/l, repeat result on analyzer (b)(6) = 10.26 pmol/l, sample id (b)(6) initial = 23.72 pmol/l, repeat result on analyzer (b)(6) = 12.95 pmol/l, sample id (b)(6) initial = 28.95 pmol/l, repeat result on analyzer (b)(6) = 14.08 pmol/l, sample id (b)(6) initial = 56.22 pmol/l, repeat result on analyzer (b)(6) = 13.08 pmol/l, sample id (b)(6) initial = 23.54 pmol/l, repeat result on analyzer (b)(6) = 13.31 pmol/l.No impact to patient management was reported.

• 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: 19093511
• MDR Text Key: 340112380
• Report Number: 3005094123-2024-00182
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P70-30
• Device Lot Number: 56159UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)