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

Catalog Number 07P70-77

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.

Event Description

The customer observed falsely elevated alinity i free t4 results for multiple samples.The following data was provided (customer provided reference range: 9.01 to 19.05 pmol/l): sample 1: initial result = 20.2 pmol/l, repeat = 13.57 pmol/l sample 2: initial result = 19.13 pmol/l, repeat = 16.33 pmol/l sample 3: initial result was >64.35 pmol/l, repeat = 15.83 pmol/l sample 4: initial result = 32.07 pmol/l, repeat = 19.59 pmol/l sample 5: initial result = 20.0 pmol/l, repeat = 11.38 pmol/l no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation 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 of a retained reagent kit lot 56201ud00, which contains the same bulk material and are identical to the complaint lot except the labeling of the outer package.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.An increase in complaints has been observed for lot 56201ud02, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 reagent kit lot 56201ud02 was identified.

Event Description

The customer observed falsely elevated alinity i free t4 results for multiple samples.The following data was provided (customer provided reference range: 9.01 to 19.05 pmol/l): sample 1: initial result = 20.2 pmol/l, repeat = 13.57 pmol/l; sample 2: initial result = 19.13 pmol/l, repeat = 16.33 pmol/l; sample 3: initial result was >64.35 pmol/l, repeat = 15.83 pmol/l; sample 4: initial result = 32.07 pmol/l, repeat = 19.59 pmol/l; sample 5: initial result = 20.0 pmol/l, repeat = 11.38 pmol/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: 19033655
• MDR Text Key: 339261489
• Report Number: 3005094123-2024-00160
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173715
• UDI-Public: (01)00380740173715(17)240831(10)56201UD02
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/09/2024

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 Catalogue Number: 07P70-77
• Device Lot Number: 56201UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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)