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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
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.
Event or Problem Description
The customer observed discrepant alinity i tsh results generated on the alinity i processing module for a 35-year-old female patient.The following data was provided: (b)(6) 2024 alinity i tsh result = 0.131 iu/ml (reference range: 0.4 to 4.3 iu/ml).On (b)(6) 2024, the patient was previously tested at another lab (diagnolab) which utilized the architect i1000sr processing module and the following tsh result was obtained: reference range: 0.350 to 4.940 iu/ml.(b)(6)2024 sid (b)(6) architect tsh results = 0.72, 0.70 iu/ml.The customer does not know which result is correct.There was no impact to patient management reported.
Additional Manufacturer Narrative
The following sections were corrected: d4 - catalog #: corrected from 07p48-30 to 07p48-20.D4 - lot #: corrected from unknown to 61389ud00.D4 - primary udi number: corrected from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.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 ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot 61389ud00 and complaint issue.The overall performance of alinity i tsh reagents was reviewed using field data from customers worldwide.The median patient result for lot 61389ud00 is comparable with other lots in the field, confirming no systemic issue for the lot.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency with the alinity i tsh reagent, lot number 61389ud00, was identified.
Event or Problem Description
The customer observed discrepant alinity i tsh results generated on the alinity i processing module for a 35-year-old female patient.The following data was provided: (b)(6) 2024 alinity i tsh result = 0.131 iu/ml (reference range: 0.4 to 4.3 iu/ml).On (b)(6) 2024, the patient was previously tested at another lab (diagnolab) which utilized the architect i1000sr processing module and the following tsh result was obtained: reference range: 0.350 to 4.940 iu/ml.(b)(6) 2024 sid (b)(6) architect tsh results = 0.72, 0.70 iu/ml.The customer does not know which result is correct.There was no impact to patient management 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: 20447557
• Report Number: 3005094123-2024-00531
• Device Sequence Number: 8524358
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)250808(10)61389UD00
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/11/2024

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: 08/08/2025
• Device Catalogue Number: 07P48-20
• Device Lot Number: 61389UD00
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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, AI26889; ALNTY I PROCESSING MODU, 03R65-01, AI26889
• Patient Age: 35 YR
• Patient Sex: Female