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	11/01/2023
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 decreased architect tsh generated on the architect i2000sr processing module for a male patient has his thyroid checked every 1 to 2 months.The following results were provided: (customer provided tsh standard value: 0.35-4.94 uiu/ml) on (b)(6) 2023 tsh result was 3.79 uiu/ml on (b)(6) 2023 repeated tsh result of the original sample was 6.11 uiu/ml the customer believes the result from (b)(6) 2023 is correct.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely decreased architect tsh generated on the architect i2000sr processing module for a male patient has his thyroid checked every 1 to 2 months.The following results were provided: (customer provided tsh standard value: 0.35-4.94 uiu/ml).(b)(6) 2023 tsh result was 3.79 uiu/ml.(b)(6) 2023 repeated tsh result of the original sample was 6.11 uiu/ml.The customer believes the result from (b)(6) 2023 is correct.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased architect tsh results generated on the architect i2000sr processing module 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.Review of all the information provided by the customer was reviewed.A review of tracking and trending did not identify any related trends for the product for the issue.Device history review did not identify any potential non-conformances, deviations, or non-conformances with the complaint lot.The overall performance of architect tsh reagent was reviewed using data gathered from customers worldwide.The median population result for the lot is within established limits, indicating that the lot(s) are performing acceptably in the field.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 51362ud00 was identified.All available patient information was included.Additional patient details are not available.

• 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: 18182574
• Report Number: 3005094123-2023-00326
• Device Sequence Number: 7653549
• 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): 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): 12/18/2023

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: 10/05/2024
• Device Catalogue Number: 07K62-25
• Device Lot Number: 51362UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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 I2000SR RFB, 03M74-98, (B)(6) ; ARC I2000SR RFB, 03M74-98, (B)(6)
• Patient Sex: Male