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	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for a patient that has a diagnosis of graves¿ disease, trab positive, and is taking mercazole 5mg daily.The following results were provided: sid (b)(6) tsh result = <0.0083 iu/ml, repeat result = 0.0086 iu/ml patient¿s previous tsh results: august tsh 0.065 iu/ml, may tsh 0.416 iu/ml, february tsh 3.189 iu/ml.Additional lab data provided: free t4 result = 1.41 ng/ml ¿ result was normal.Free t3 result is elevated, however, no specific data provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed alinity i tsh 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 field data review.Return testing was not completed as returns were not available.Data and information provided by the customer confirm the complaint issue.The ticket search by lot indicates that the reagent lots performed as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.The device history record review on lot 58166ud00 did not show any deviations or non-conformances associated with the complaint issue.The overall performance of alinity i tsh reagent was reviewed using worldwide field data.The median population result for the complaint lot are within established limits, indicating that the lot are performing acceptably in the field.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the alinity i tsh assay for lot number 58166ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for a patient that has a diagnosis of graves¿ disease, trab positive, and is taking mercazole 5mg daily.The following results were provided: sid (b)(6) tsh result = <0.0083 iu/ml, repeat result = 0.0086 iu/ml.Patient¿s previous tsh results: (b)(6) tsh 0.065 iu/ml, (b)(6) tsh 0.416 iu/ml, (b)(6) tsh 3.189 iu/ml.Additional lab data provided: free t4 result = 1.41 ng/ml ¿ result was normal free t3 result is elevated, however, no specific data provided 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: 20278891
• Report Number: 3005094123-2024-00489
• Device Sequence Number: 20723822
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)250509(10)58166UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 05/09/2025
• Device Catalogue Number: 07P48-20
• Device Lot Number: 58166UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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