MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07P48-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = sid (b)(6).
Event or Problem Description
The customer observed falsely depressed results for alinity thyroid stimulating hormone (tsh) for one patient.The results were not reported out.The customer repeated the patient with higher results on the architect.The following data provided: sid (b)(6) alinity result = 0.21 miu/l processed on (b)(6) 2024 normal range = 0.4-4.0 miu/l architect result = 11 miu/l processed on (b)(6) 2024 no impact to patient management was reported.
Additional 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 field data review.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 ticket search by lot indicates that the reagent lot 56154ud00 performs as expected for the product.The ticket trending review did not identify any related trends for the product for the complaint issue.A review of the device history record did not identify any non-conformances or deviations associated with the reagent lot and the complaint issue.Customer field data was used to assess the performance of the alinity i tsh assay using worldwide data.The review shows that the median patient results for lot 56154ud00 is within established limits and comparable with other lots in the field confirming no systemic issue for the lot.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity i tsh reagent lot 56154ud00 was identified.
Event or Problem Description
The customer observed falsely depressed results for alinity thyroid stimulating hormone (tsh) for one patient.The results were not reported out.The customer repeated the patient with higher results on the architect.The following data provided: sid (b)(6) alinity result = 0.21 miu/l processed on 13mar2024 normal range = 0.4-4.0 miu/l architect result = 11 miu/l processed on (b)(6) 2024 no impact to patient management was reported.

• Brand Name: ALINITY I TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 18968934
• Report Number: 3005094123-2024-00138
• Device Sequence Number: 6694045
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)250228(10)56154UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 07P48-20
• Device Lot Number: 56154UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown