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 03/26/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i free t4 results for one patient with different sids.The following results were provided: (laboratory normal reference range for free t4: 9 to 19 pmol/l) 26mar2024 sid (b)(6) initial result 13.5 pmol/l, repeat results were > 64.35 pmol/l ((b)(6)), > 64.4 pmol/l, > 64.4 pmol/l, 17.6 pmol/l the customer is only questioning the free t4 results.Additional lab results provided: tsh 0.730 miu/l, ferritin 132.9 ng/ml, vitamin b12 194 pg/ml, folate 3.3 ng/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.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity free t4 results 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.Review of all the information provided by the customer was reviewed.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not show any nonconformances, potential nonconformances or deviations associated with the likely cause list number 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.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity free t4 for lot number 57607ud00 was identified.Corrected information in section d8 - was device serviced by third party?, section d9 - device available for evaluation 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 one patient with different sids.The following results were provided: (laboratory normal reference range for free t4: 9 to 19 pmol/l).(b)(6) 2024 sid (b)(6) initial result 13.5 pmol/l, repeat results were > 64.35 pmol/l (ai24460), > 64.4 pmol/l, > 64.4 pmol/l, 17.6 pmol/l.The customer is only questioning the free t4 results.Additional lab results provided: tsh 0.730 miu/l, ferritin 132.9 ng/ml, vitamin b12 194 pg/ml, folate 3.3 ng/ml.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: 19058493
• MDR Text Key: 339565399
• Report Number: 3005094123-2024-00172
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(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: 04/08/2024
• 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
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)