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	12/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect tsh results for two patients.The samples were repeated and higher results were obtained.It was reported that error code 3000 (liquid level sense) and error code 3350 (aspiration error) were also generated on the architect tsh reagent.The following data was provided: (b)(6) 2023 sid (b)(6) tsh result = 0.0155 iu/ml; repeat result = 0.6473 iu/ml.(b)(6) 2023 sid (b)(6) tsh result = 0.0053 iu/ml; repeat result = 0.6473 iu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased architect tsh results 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 the reagent lot is performing 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 the lot number 54190ud00 and complaint issue.The overall performance of the architect tsh reagent was reviewed using field data from customers worldwide.The median population result for lot 54190ud00 is within established limits, indicating that the lot is performing acceptably in the field.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the architect tsh reagent, lot number 54190ud00.
Event or Problem Description
The customer observed falsely decreased architect tsh results for two patients.The samples were repeated and higher results were obtained.It was reported that error code 3000 (liquid level sense) and error code 3350 (aspiration error) were also generated on the architect tsh reagent.The following data was provided: 25dec2023 sid (b)(6) tsh result = 0.0155 iu/ml; repeat result = 0.6473 iu/ml 25dec2023 sid (b)(6) tsh result = 0.0053 iu/ml; repeat result = 0.6473 iu/ml there was no impact to patient management 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: 18480916
• Report Number: 3005094123-2024-00020
• Device Sequence Number: 6408352
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• 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): 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): 01/14/2024

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: 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: 12/25/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/14/2024
• 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 I2K PROC MOD, 03M74-01, ISR51565; ARC I2K PROC MOD, 03M74-01, ISR51565
• Patient Sex: Unknown