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

Catalog Number	07K62-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed architect tsh results for one sample.The following data was provided: initial result = 67 iu/ml, repeat on an alinity was >100 iu/ml, repeat with 1:5 dilution on the alinity = 123 iu/ml a result of 123 iu/ml was reported out of the laboratory.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 search for similar complaints did not identify an increase in complaint activity for lot 61058ud00.Ticket trending review did not identify any trends for the issue for the product.Device history review did not identify any non-conformances or deviations with lot number 61058ud00 and the complaint issue.The overall performance of the architect tsh reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 61058ud00 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 61058ud00 was identified.
Event or Problem Description
The customer observed falsely depressed architect tsh results for one sample.The following data was provided: initial result = 67 iu/ml, repeat on an alinity was >100 iu/ml, repeat with 1:5 dilution on the alinity = 123 iu/ml.A result of 123 iu/ml was reported out of the laboratory.No impact to patient management was reported.

• Brand Name: ARCHITECT 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: 20142207
• Report Number: 3005094123-2024-00460
• Device Sequence Number: 3187637
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250711(10)61058UD00
• 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): 11/19/2024

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: 07/11/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 61058UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: ARC I2K PROC MOD, 03M74-01, ISR54204; ARC I2K PROC MOD, 03M74-01, ISR54204
• Patient Sex: Unknown