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 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 patient identifier: sid (b)(6).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 results for a 84 year old male patient.The patient was previously diagnosed with hypothyroidism in (b)(6) 2022 and was started on the medication thyradin.The following information was provided (customer provided reference ranges: free t4 is 0.70 to 1.48 ng/dl, tsh is 0.35 to 4.94 uiu/ml): (b)(6) 2024: free t4 = 2.66 ng/dl, repeat at another laboratory generated results within the normal range, free t3 = 2.51, tsh = 6.22 uiu/ml.(b)(6) 2024 sid (b)(6) : free t4 = 1.27 ng/dl, repeat = 0.86 ng/dl.Free t3 = 2.27, repeat = 2.12.Tsh = 4.93 uiu/ml, repeat = 6.08 uiu/ml.Patient history (cardiovascular examinations with chf, hypertension, and ischemic heart disease) and historical results: (b)(6) 2022: tsh = 20.23 uiu/ml, free t4 = 0.84 ng/dl, free t3 = 2.36.The patient was referred to the current department and diagnosed with hypothyroidism and started on thyradin 12.5 ug.(b)(6) 2022: the patient didn¿t have a repeat visit and the medication was discontinued.(b)(6) 2023: tsh = 6.88 uiu/ml, free t4 = 1.29 ng/dl.(b)(6) 2023: tsh = 16.34 uiu/ml, free t4 = 0.98 ng/dl.The patient was restarted on thyradin 12.5 ug.(b)(6) 2023: tsh = 16.37 uiu/ml, free t4 = 1.11 ng/dl.The thyradin was increased to 25 ug.(b)(6) 2023: tsh = 4.95 uiu/ml, free t4 = 1.36 ng/dl.(b)(6) 2023: tsh = 2.8 uiu/ml, free t4 = 1.68 ng/dl.The thyradin was reduced to 12.5/25 ug every other day.The customer is questioning the alinity i free t4 results generated on (b)(6) 2024 and (b)(6) 2024.The patient¿s medication has not changed due to the falsely elevated alinity i free t4 results.The customer is not questioning the alinity i tsh results.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: 19070454
• MDR Text Key: 339879528
• Report Number: 3005094123-2024-00176
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)240503(10)51650UD00
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/09/2024

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 Expiration Date: 05/03/2024
• Device Catalogue Number: 07P70-20
• Device Lot Number: 51650UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2023
• 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)
• Patient Age: 84 YR
• Patient Sex: Male