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

Catalog Number 07K65-77

Device Problem High Test Results (2457)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The customer reported falsely elevated architect free t4 results for 5 patients.The following data was provided (customer¿s reference range: (b)(6): patient 2: initial result = 19.73 pmol/l; repeat result = 17.56 pmol/l patient 3: initial result = 26.82 pmol/l; repeat result = 14.70 pmol/l patient 4: initial result = 27.48 pmol/l; repeat result = 15.53 pmol/l patient 5: initial result = 20.12 pmol/l; repeat result = 13.90 pmol/l patient 6: initial result = 23.69 pmol/l; repeat result = 16.94 pmol/l there was no impact to patient management reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.B5 - describe event or problem: added additional patient's results that were provided on (b)(6) 2024.

Event Description

On (b)(6) 2024, the customer reported another patient sample for falsely elevated architect free t4 results when retested.The initial free t4 result was 24.99 pmol/l and the repeat result was 11.33 pmol/l (reference range: 9.01-19.05 pmol/l).There was no impact to patient management reported.

Event Description

The customer reported falsely elevated architect free t4 results for 5 patients.The following data was provided (customer¿s reference range: 9.01-19.05 pmol/l): patient 2: initial result = 19.73 pmol/l; repeat result = 17.56 pmol/l patient 3: initial result = 26.82 pmol/l; repeat result = 14.70 pmol/l patient 4: initial result = 27.48 pmol/l; repeat result = 15.53 pmol/l patient 5: initial result = 20.12 pmol/l; repeat result = 13.90 pmol/l patient 6: initial result = 23.69 pmol/l; repeat result = 16.94 pmol/l.On 30mar2024, the customer reported another patient sample for falsely elevated architect free t4 results when retested.The initial free t4 result was 24.99 pmol/l and the repeat result was 11.33 pmol/l (reference range: 9.01-19.05 pmol/l).There was no impact to patient management reported.

Manufacturer Narrative

Correction: d4 - catalog #: initial: 07k65-34 / updated to 07k65-77.D4 - lot # initial: 50481ud00 / updated to 50481ud02.D4 - primary udi number initial: (b)(4).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Upon review: h4 - device mfg date - initial: 4/21/2023 / updated to 4/26/2023.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 50481ud02.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.A search for similar complaints did identify an increase in complaint activity for lot 50481ud02, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, 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 architect free t4 reagent lot 50481ud02 was identified.

Event Description

The customer reported falsely elevated architect free t4 results for 5 patients.The following data was provided (customer¿s reference range: 9.01-19.05 pmol/l): patient 2: initial result = 19.73 pmol/l; repeat result = 17.56 pmol/l patient 3: initial result = 26.82 pmol/l; repeat result = 14.70 pmol/l patient 4: initial result = 27.48 pmol/l; repeat result = 15.53 pmol/l patient 5: initial result = 20.12 pmol/l; repeat result = 13.90 pmol/l patient 6: initial result = 23.69 pmol/l; repeat result = 16.94 pmol/l on (b)(6) 2024, the customer reported another patient sample for falsely elevated architect free t4 results when retested.The initial free t4 result was 24.99 pmol/l and the repeat result was 11.33 pmol/l (reference range: 9.01-19.05 pmol/l).There was no impact to patient management reported.

• Brand Name: ARCHITECT 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: 18691455
• MDR Text Key: 335185739
• Report Number: 3005094123-2024-00057
• 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,Followup,Followup,Followup
• Report Date: 05/29/2024

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 Expiration Date: 03/06/2024
• Device Catalogue Number: 07K65-77
• Device Lot Number: 50481UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/30/2024; 04/24/2024; Not provided
• Supplement Dates FDA Received: 04/02/2024; 04/25/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)