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	12/15/2023
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.Section a1 patient identifier complete sid: (b)(6).
Event or Problem Description
The customer reported a falsely decreased architect tsh result on a 10-yr old male patient.Results provided: (b)(6) 2023 architect sid (b)(6) = 0.146 / 0.2660 uiu/ml, another alinity = 0.2306 uiu/ml (normal range: 0.700-5.700 uiu/ml) (b)(6) 2023 roche = 1.510 uiu/ml (normal range: 0.60-4.84 uiu/ml) no impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause architect tsh reagent lot 53205ud00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Historical performance in the field of reagent lot using worldwide data was evaluated.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.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation no systemic issue or product deficiency of the architect tsh reagent lot 53205ud00 was identified.
Event or Problem Description
The customer reported a falsely decreased architect tsh result on a 10-yr old male patient.Results provided: (b)(6)2023 architect sid (b)(6)= 0.146 / 0.2660 uiu/ml, another alinity = 0.2306 uiu/ml (normal range: 0.700-5.700 uiu/ml) (b)(6)2023 roche = 1.510 uiu/ml (normal range: 0.60-4.84 uiu/ml) 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: 18462791
• Report Number: 3005094123-2024-00011
• Device Sequence Number: 15220352
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 02/21/2024

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: 11/30/2024
• Device Catalogue Number: 07K62-25
• Device Lot Number: 53205UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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 MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Age: 10 YR
• Patient Sex: Male