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	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: (b)(6) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely decreased architect tsh result for a patient sample.The following data was provided (reference range 0.35-4.94 miu/l): (b)(6) 2023 sample id 946737 initial result = aspiration error ec 3350, repeat = 0.292 miu/l same patient, new sample obtained.Sample id 947560 results = 3.4883 and 3.3298 miu/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect 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 were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends for the complaint lot.Device history record review did not identify any non-conformances or deviations with the complaint lot and issue.Historical performance was reviewed using data gathered from customers worldwide.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the architect tsh reagent lot 54190ud00 was identified.
Event or Problem Description
The customer observed a falsely decreased architect tsh result for a patient sample.The following data was provided (reference range 0.35-4.94 miu/l): on (b)(6) 2023 sample id (b)(6) initial result = aspiration error ec 3350, repeat = 0.292 miu/l same patient, new sample obtained.Sample id (b)(6) results = 3.4883 and 3.3298 miu/l 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: 18073958
• Report Number: 3005094123-2023-00302
• Device Sequence Number: 18058720
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/12/2023

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: 12/27/2024
• Device Catalogue Number: 07K62-25
• Device Lot Number: 54190UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown