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	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed architect tsh results for a premature infant baby who¿s mother has a history of hypothyroidism.The following data was provided: abbott reference range: 0.35 to 4.94 uiu/ml, roche cobas reference range: 0.35 to 4.94 uiu/ml.(b)(6) 2024, sid (b)(6): isr60121 = 0.177 uiu/ml, repeat = 15.169 uiu/ml, roche cobas = 32.11 uiu/ml, repeat = 31.27 uiu/ml.(b)(6) 2024, sample 2: isr60121 = 0.310 uiu/ml, repeat = 12.907 uiu/ml, roche cobas = 20.66 uiu/ml.Additional laboratory data provided: trab result = 0.8 iu/l (normal range: <1.75 iu/l), ft3 = 1.18 nmol/l (normal range: 1.30 to 3.10 nmol/l), ft4 = 17.2 pmol/l (normal range: 12 to 22 pmol/l).No impact to patient management was reported.
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.
Additional Manufacturer Narrative
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, field data review and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer confirm the complaint issue.Review of tracking and trending for the architect tsh assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot: 56169ud00.A device history record review did not identify any non-conformance's, deviations, or potential non-conformance's associated with lot: 56169ud00 and complaint issue.The overall performance of the architect tsh was reviewed using field data from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot: 56169ud00 is within the established control limits.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect tsh lot: 56169ud00 was identified.
Event or Problem Description
The customer observed falsely depressed architect tsh results for a premature infant baby who¿s mother has a history of hypothyroidism.The following data was provided: abbott reference range: 0.35 to 4.94 uiu/ml, roche cobas reference range: 0.35 to 4.94 uiu/ml on (b)(6) 2024, sid: (b)(6): isr60121 = 0.177 uiu/ml, repeat = 15.169 uiu/ml, roche cobas = 32.11 uiu/ml, repeat = 31.27 uiu/ml on (b)(6) 2024, sample (b)(6): isr60121 = 0.310 uiu/ml, repeat = 12.907 uiu/ml, roche cobas = 20.66 uiu/ml additional laboratory data provided: trab result = 0.8 iu/l (normal range: <1.75 iu/l), ft3 = 1.18 nmol/l (normal range: 1.30 to 3.10 nmol/l), ft4 = 17.2 pmol/l (normal range: 12 to 22 pmol/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: 21003028
• Report Number: 3005094123-2024-00662
• Device Sequence Number: 9867240
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250306(10)56169UD00
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 03/05/2025

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: 03/06/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 56169UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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 INST, 03M74-02, ISR60121.; ARC I2000SR INST, 03M74-02, ISR60121.
• Patient Sex: Unknown