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 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.

Event Description

The customer observed falsely elevated alinity i free t4 results.The following data was provided:.On (b)(6) 2024, for sid (b)(6) the initial result was >5.0 ng/l, repeated without dilution and obtained a result of 1.09 ng/dl (normal).On (b)(6) 2024, sid (b)(6) initial result was 4.17 ng/dl, repeated on a different module (b)(6) and the result was 0.90 ng/dl.On (b)(6) 2024, sid (b)(6) initial result was > 5.0 ng/l, repeated without dilution, generated a result of 2.30 ng/l.On (b)(6) 2024, sid (b)(6) -serum initial result was > 5.0 ng/l (b)(6), repeated without dilution, on another instrument (b)(6) which also generated a result > 5.0 ng/l.In a new sample, of plasma material, the result for sid (b)(6) -plasma was 1.22 ng/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: 19121230
• MDR Text Key: 340686934
• Report Number: 3005094123-2024-00186
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)240810(10)56159UD00
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/16/2024

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: 07P70-30
• Device Lot Number: 56159UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/16/2024
• 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)