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

Catalog Number	07P50-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity i estradiol results generated for patient samples.The following data was provided: on (b)(6) 2025 sample id (b)(6) = 858.93 pg/ml, (b)(6) 2025 sample was diluted and repeat result = 2541.91 pg/ml, repeat result at another laboratory = 2515.97 pg/ml.Sample id (b)(6) initial result = 782 pg/ml, sample was sent to another laboratory and diluted.Result = 1314 pg/ml.Sample id (b)(6) initial result = 893 pg/ml, sample was sent to another laboratory and diluted.Result = 1259 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).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, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review did not identify an increase in complaint activity for the reported event.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the alinity i estradiol reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 70601ud00 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i estradiol reagent lot 70601ud00 was identified.
Event or Problem Description
The customer observed falsely depressed alinity i estradiol results generated for patient samples.The following data was provided: on (b)(6) 2025, sample id (b)(6), = 858.93 pg/ml, (b)(6) 2025 sample was diluted and repeat result = 2541.91 pg/ml, repeat result at another laboratory = 2515.97 pg/ml.Sample id (b)(6), initial result = 782 pg/ml, sample was sent to another laboratory and diluted.Result = 1314 pg/ml.Sample id (b)(6), initial result = 893 pg/ml, sample was sent to another laboratory and diluted.Result = 1259 pg/ml.No impact to patient management was reported.

• Brand Name: ALINITY I 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: 22077605
• Report Number: 3005094123-2025-00252
• Device Sequence Number: 18476056
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: (01)00380740129910(17)251004(10)70601UD00
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/19/2025

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: 10/04/2025
• Device Catalogue Number: 07P50-20
• Device Lot Number: 70601UD00
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown