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

Catalog Number 07P70-30

Device Problem False Positive Result (1227)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, 1.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 reported a falsely elevated alinity i free t4 (ft4) result on one patient.The following results provided were: on (b)(6) 2024 sid (b)(6) initial= 20.6 pmol/l /repeated on (b)(6) 2024= 14.4 pmol/l which corelated with patient history.Repeated=12.54, 13.19, 12.94, 12.71 and 12.66 pmol/l there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing for alinity i free t4 result reagent lot: 57607ud00.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.In-house testing was completed using an in-house retained kit.All specifications were met indicating that the lot is performing acceptably.A review of the labeling addresses the customer¿s issue.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the alinity i free t4 result reagent lot: 57607ud00.

Event Description

The customer reported a falsely elevated alinity i free t4 (ft4) result on one patient.The following results provided were: on (b)(6)2024 sid (b)(6)initial= 20.6 pmol/l /repeated on (b)(6)2024= 14.4 pmol/l which corelated with patient history repeated=12.54, 13.19, 12.94, 12.71 and 12.66 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: 19018982
• MDR Text Key: 339116558
• Report Number: 3005094123-2024-00159
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 380740121822
• UDI-Public: (01)380740121822(17)241031(10)57607UD00
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Report Date: 04/12/2024

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: 57607UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• 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
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)