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 03/14/2024

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 was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated alinity i free t4 results for a patient sample.The following information was provided (reference range 7.0-14.8 pg/ml): 14mar sample id (b)(6) initial result = 18.1 pg/ml, repeat = >50 pg/ml, 11.6 pg/ml.Additional results provided: tsh initial result = 0.86 miu/l.Ft3 initial result = 2.2 ng/l.No impact to patient management was reported.

Event Description

The customer observed falsely elevated alinity i free t4 results for a patient sample.The following information was provided (reference range 7.0-14.8 pg/ml): 14mar sample id (b)(6) initial result = 18.1 pg/ml, repeat = >50 pg/ml, 11.6 pg/ml additional results provided: tsh initial result = 0.86 miu/l.Ft3 initial result = 2.2 ng/l.No impact to patient management was reported.Additional information provided on 28mar2024.Additional patients had falsely elevated alinity i free t4 results generated.The following information was provided: 28mar2024 sample id (b)(6).Initial result on analyzer (b)(6) = 15.7 pg/ml, repeat result after re-centrifugation on analyzer (b)(6) = 12.1 pg/ml.Tsh result = 1.09 miu/l (normal).Sample id (b)(6) initial result on analyzer (b)(6) = 15.2 pg/ml, repeat result after re-centrifugation = 11.9 pg/ml.Tsh result = 2.95 miu/l.Ft3 result = 3.40 ng/l.No impact to patient management was reported.

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.Update: a1 - patient identifier updated from (b)(6) to multiple.Completed information for section a1 patient identification: sids (b)(6).Additional information in section b5 event description.Additional information in section d10 concomitant product.

Event Description

The customer observed falsely elevated alinity i free t4 results for a patient sample.The following information was provided (reference range 7.0-14.8 pg/ml): (b)(6) sample id (b)(6) initial result = 18.1 pg/ml, repeat = >50 pg/ml, 11.6 pg/ml additional results provided: tsh initial result = 0.86 miu/l.Ft3 initial result = 2.2 ng/l.No impact to patient management was reported.Additional information provided on 28mar2024.Additional patients had falsely elevated alinity i free t4 results generated.The following information was provided: (b)(6) 2024 sample id (b)(6).Initial result on analyzer (b)(6) = 15.7 pg/ml, repeat result after re-centrifugation on analyzer (b)(6) = 12.1 pg/ml tsh result = 1.09 miu/l (normal).Sample id (b)(6) initial result on analyzer (b)(6) = 15.2 pg/ml, repeat result after re-centrifugation = 11.9 pg/ml tsh result = 2.95 miu/l ft3 result = 3.40 ng/l no impact to patient management was reported.Additional information provided on 16apr2024.Additional patient with falsely elevated free t4 result generated on analyzer (b)(6).The following information was provided: (b)(6) 2024 sample id (b)(6).Initial result = 15.8 pg/ml, repeat results = 13.1 pg/ml, and 19.4 pg/ml sample recentrifuged and result = 13.4 pg/ml same patient, new sample obtained and result = 14 pg/ml no impact to patient management was reported.

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.Update to previous h11: completed information for section a1 patient identification: sids (b)(6).Additional patient information in section b5 event description.

• 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: 18983430
• MDR Text Key: 338688387
• Report Number: 3005094123-2024-00142
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)241004(10)57272UD00
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2023
• 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) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)