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 02/22/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i free t4 results for multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l) initial result = 20.82 pmol/l, repeat result = 16.32 pmol/l initial result = 20.64 pmol/l, repeat result = 16.98 pmol/l initial result = 19.63 pmol/l, repeat result = 17.56 pmol/l initial result = 20.05 pmol/l, repeat result = 17.52 pmol/l initial result = 20.28 pmol/l, repeat result = 18.23 pmol/l initial result = 21.19 pmol/l, repeat result = 15.19 pmol/l the following results were performed on (b)(6) 2024: sample 1 initial result 27.56 pmol/l, repeat result = 18.58 pmol/l sample 2 initial result 23.31 pmol/l, repeat result = 17.25 pmol/l sample 3 initial result 25.69 pmol/l, repeat result = 18.32 pmol/l sample 5 initial result 19.43 pmol/l, repeat result = 17.01 pmol/l sample 6 initial result 19.63 pmol/l, repeat result = 17.11 pmol/l sample 7 initial result 20.93 pmol/l, repeat result = 17.26 pmol/l sample 11 initial result 19.71 pmol/l, repeat result = 16.51 pmol/l sample 12 initial result 32.09 pmol/l, repeat result = 17.63 pmol/l sample 13 initial result 21.70 pmol/l, repeat result = 19.21 pmol/l sample 14 initial result 19.10 pmol/l, repeat result = 14.52 pmol/l sample 15 initial result 22.82 pmol/l, repeat result = 17.15 pmol/l sample 16 initial result 20.89 pmol/l, repeat result = 18.57 pmol/l sample 17 initial result 20.96 pmol/l, repeat result = 16.60 pmol/l sample 18 initial result 21.83 pmol/l, repeat result = 15.89 pmol/l sample 19 initial result 21.31 pmol/l, repeat result = 17.41 pmol/l sample 21 initial result 23.22 pmol/l, repeat result = 17.44 pmol/l sample 23 initial result 19.25 pmol/l, repeat result = 15.05 pmol/l sample 24 initial result 20.18 pmol/l, repeat result = 15.94 pmol/l sample 25 initial result 20.08 pmol/l, repeat result = 15.39 pmol/l sample 26 initial result 19.70 pmol/l, repeat result = 15.52 pmol/l sample 27 initial result 20.64 pmol/l, repeat result = 16.65 pmol/l sample 29 initial result 26.16 pmol/l, repeat result = 21.09 pmol/l sample 31 initial result 19.30 pmol/l, repeat result = 15.49 pmol/l sample 32 initial result 21.27 pmol/l, repeat result = 15.61 pmol/l sample 33 initial result 21.30 pmol/l, repeat result = 12.79 pmol/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.A1 patient identifier complete information: sample 1, sample 2,sample 3,sample 5,sample 6,sample 7,sample 11,sample 12,sample 13,sample 14,sample 15,sample 16,sample 17,sample 18,sample 19,sample 21,sample 23,sample 24,sample 25,sample 26,sample 27,sample 29,sample 31,sample 32,sample 33 all available patient information was included.Additional patient details are not available.

Manufacturer Narrative

Updated information in section d4 primary udi number.The complaint investigation for falsely elevated alinity i 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.Data and information provided by the customer was reviewed and support the complaint issue.Return testing was not performed as returns were not available.An increase in complaints has been observed for lot 56201ud02, however, in-house performance for lot 56201ud00 was completed which indicates the product is performing as expected.Please note that the likely cause for this complaint is 56201ud02 and is a sublot of 56201ud00.The device history record review did not show any nonconformances, potential nonconformances, or deviations associated with lot number 56201ud02 and complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot number 56201ud02 was identified.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 multiple samples.The following results were provided: (customer provided reference range 9.01-19.05 pmol/l).Initial result = 20.82 pmol/l, repeat result = 16.32 pmol/l.Initial result = 20.64 pmol/l, repeat result = 16.98 pmol/l.Initial result = 19.63 pmol/l, repeat result = 17.56 pmol/l.Initial result = 20.05 pmol/l, repeat result = 17.52 pmol/l.Initial result = 20.28 pmol/l, repeat result = 18.23 pmol/l.Initial result = 21.19 pmol/l, repeat result = 15.19 pmol/l.The following results were performed on (b)(6) 2024: sample 1 initial result 27.56 pmol/l, repeat result = 18.58 pmol/l.Sample 2 initial result 23.31 pmol/l, repeat result = 17.25 pmol/l.Sample 3 initial result 25.69 pmol/l, repeat result = 18.32 pmol/l.Sample 5 initial result 19.43 pmol/l, repeat result = 17.01 pmol/l.Sample 6 initial result 19.63 pmol/l, repeat result = 17.11 pmol/l.Sample 7 initial result 20.93 pmol/l, repeat result = 17.26 pmol/l.Sample 11 initial result 19.71 pmol/l, repeat result = 16.51 pmol/l.Sample 12 initial result 32.09 pmol/l, repeat result = 17.63 pmol/l.Sample 13 initial result 21.70 pmol/l, repeat result = 19.21 pmol/l.Sample 14 initial result 19.10 pmol/l, repeat result = 14.52 pmol/l.Sample 15 initial result 22.82 pmol/l, repeat result = 17.15 pmol/l.Sample 16 initial result 20.89 pmol/l, repeat result = 18.57 pmol/l.Sample 17 initial result 20.96 pmol/l, repeat result = 16.60 pmol/l.Sample 18 initial result 21.83 pmol/l, repeat result = 15.89 pmol/l.Sample 19 initial result 21.31 pmol/l, repeat result = 17.41 pmol/l.Sample 21 initial result 23.22 pmol/l, repeat result = 17.44 pmol/l.Sample 23 initial result 19.25 pmol/l, repeat result = 15.05 pmol/l.Sample 24 initial result 20.18 pmol/l, repeat result = 15.94 pmol/l.Sample 25 initial result 20.08 pmol/l, repeat result = 15.39 pmol/l.Sample 26 initial result 19.70 pmol/l, repeat result = 15.52 pmol/l.Sample 27 initial result 20.64 pmol/l, repeat result = 16.65 pmol/l.Sample 29 initial result 26.16 pmol/l, repeat result = 21.09 pmol/l.Sample 31 initial result 19.30 pmol/l, repeat result = 15.49 pmol/l.Sample 32 initial result 21.27 pmol/l, repeat result = 15.61 pmol/l.Sample 33 initial result 21.30 pmol/l, repeat result = 12.79 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: 18848006
• MDR Text Key: 337297800
• Report Number: 3005094123-2024-00094
• Device Sequence Number: 1
• Product Code: CEC
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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)