MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Catalog Number	07K72-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 reported a falsely decreased architect estradiol result on a 32-yr old female patient the following results were provided: (b)(6) 2025 architect = 434 pg/ml; another laboratory (electrochemiluminescence) = 520 pg/ml; another laboratory (chemiluminescence) = 384 pg/ml; another laboratory = 1029.30 pg/ml 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 patient added on (b)(6) 2025, sid (b)(6), (32-yr old female).
Event or Problem Description
The customer reported falsely a decreased architect estradiol result on a 32-yr old female patient the following results were provided: on (b)(6) 2025 architect = 434 pg/ml; another laboratory (electrochemiluminescence) = 520 pg/ml; another laboratory (chemiluminescence) = 384 pg/ml; another laboratory = 1029.30 pg/ml additional patient added on (b)(6) 2025: (b)(6) 2025 (32-yr old female) = sid (b)(6) = 434 pg/ml; another laboratory = 384.00 pg/ml; another laboratory = 1029.3 pg/ml; another laboratory = 520.0 pg/ml.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely a decreased architect estradiol result on a 32-yr old female patient the following results were provided: on (b)(6) 2025 architect = 434 pg/ml; another laboratory (electrochemiluminescence) = 520 pg/ml; another laboratory (chemiluminescence) = 384 pg/ml; another laboratory = 1029.30 pg/ml.Additional patient added on (b)(6) 2025: (b)(6) 2025 (32-yr old female) = sid (b)(6) = 434 pg/ml; another laboratory = 384.00 pg/ml; another laboratory = 1029.3 pg/ml; another laboratory = 520.0 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity for lot 68273ud00 did not identify an increase.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Customer field data was used to assess the performance of the architect assay using worldwide data.Review shows that the median patient results for lot 68273ud00 is comparable with other lots in the field confirming no systemic issue for the lot.A review of product labeling was performed which provides appropriate information related to the customer¿s issue.Based on the available information, no deficiency of the architect estradiol assay was identified.

• Brand Name: ARCHITECT ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• 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: 21941035
• Report Number: 3005094123-2025-00207
• Device Sequence Number: 8553722
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: (01)00380740014711(17)250706(10)68273UD00
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 07/17/2025

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: 07/06/2025
• Device Catalogue Number: 07K72-25
• Device Lot Number: 68273UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 07/17/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• 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 I1SR REFURB-MEXICO, 01L86-84, (B)(6),; ARC I1SR REFURB-MEXICO, 01L86-84, (B)(6),; ARC I1SR REFURB-MEXICO, 01L86-84, (B)(6).
• Patient Age: 32 YR
• Patient Sex: Female