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 02/29/2024

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 result generated on the alinity i processing module for six patients.The samples were repeated and normal results were obtained.The following data was provided: customer¿s normal range: 9.01 to 19.05 pmol/l.Patient 1 initial result = 19.32 pmol/l; repeat result = 16.46 pmol/l.Patient 2 initial result = 19.26 pmol/l; repeat result = 17.33 pmol/l.Patient 3 initial result = 25.04 pmol/l; repeat result = 18.78 pmol/l.Patient 4 initial result = 20.49 pmol/l; repeat result = 15.53 pmol/l.Patient 5 initial result = 23.24 pmol/l; repeat result = 18.90 pmol/l.Patient 6 initial result = 22.34 pmol/l; repeat result = 16.74 pmol/l.There was no impact to patient management reported.

Manufacturer Narrative

Section d4 - lot #: the lot# was corrected from 57607ud01 to 57607ud02.Section d4 - catalog #: this section was corrected from 07p70-30 to 07p70-77.Section d4 - primary udi number: this section was corrected from (b)(4).The complaint investigation for falsely elevated alinity i free t4 results included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.In addition, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of the complaint trending report did identify an increase in complaints for lot 57607ud02, however, in-house performance testing was completed which indicates the product is performing as expected.A review of the device history record did not identify any non-conformances or deviations with lot number 57607ud02 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 57607ud02.

Event Description

The customer observed falsely elevated alinity i free t4 result generated on the alinity i processing module for six patients.The samples were repeated and normal results were obtained.The following data was provided: customer¿s normal range: 9.01 to 19.05 pmol/l patient 1 initial result = 19.32 pmol/l; repeat result = 16.46 pmol/l patient 2 initial result = 19.26 pmol/l; repeat result = 17.33 pmol/l patient 3 initial result = 25.04 pmol/l; repeat result = 18.78 pmol/l patient 4 initial result = 20.49 pmol/l; repeat result = 15.53 pmol/l patient 5 initial result = 23.24 pmol/l; repeat result = 18.90 pmol/l patient 6 initial result = 22.34 pmol/l; repeat result = 16.74 pmol/l there was no impact to patient management 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: 18980533
• MDR Text Key: 338982310
• Report Number: 3005094123-2024-00141
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)241031(10)57607UD02
• 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: 04/30/2024

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: 57607UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/30/2024
• 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)