MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Model Number	7K72-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: complete sid is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect estradiol result for one patient.The result was reported to the physician who questioned the result.The patient previously had an elevated estradiol result of 2000 pg/ml with a risk of thromboembolism.The same sample was repeated, and the results were higher.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 942 pg/ml (undiluted).(b)(6) 2023 sid (b)(6) 1st repeat result = 1000 pg/ml (undiluted); dilution 1:5 result = 3354 pg/ml.(b)(6) 2023 sid (b)(6) 2nd repeat result = 1000 pg/ml (undiluted); dilution 1:5 result = 3729.319 pg/ml patient¿s previous result = 2000 pg/ml no impact to patient management was reported.
Additional Manufacturer Narrative
Section a3-gender: added gender.Section b5-describe event or problem: additional information has been added.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
On 01mar2023, the customer provided additional information on this patient.The patient is female who is having an ongoing treatment with fyremadel, menopur 112, and folic acid.
Event or Problem Description
The customer observed falsely decreased architect estradiol result for one patient.The result was reported to the physician who questioned the result.The patient previously had an elevated estradiol result of > 2000 pg/ml with a risk of thromboembolism.The same sample was repeated, and the results were higher.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 942 pg/ml (undiluted).(b)(6) 2023 sid (b)(6) 1st repeat result = > 1000 pg/ml (undiluted); dilution 1:5 result = 3354 pg/ml.(b)(6) 2023 sid 530121101018 2nd repeat result = > 1000 pg/ml (undiluted); dilution 1:5 result = 3729.319 pg/ml.Patient¿s previous result = > 2000 pg/ml.No impact to patient management was reported.On 01mar2023, the customer provided additional information on this patient.The patient is female who is having an ongoing treatment with fyremadel, menopur 112, and folic acid.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased architect estradiol result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling 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.Ticket search by lot indicates the reagent lot is performing as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 40252ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect estradiol assay for lot 40252ud00 was identified.

• Brand Name: ARCHITECT ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16384825
• Report Number: 3005094123-2023-00044
• Device Sequence Number: 5515031
• Product Code: CHP
• UDI-Device Identifier: 00380740106065
• UDI-Public: 00380740106065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/09/2023

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: 03/11/2023
• Device Model Number: 7K72-35
• Device Catalogue Number: 07K72-35
• Device Lot Number: 40252UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 05/03/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/16/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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 I2SR REFURB-SEKAT, 03M74-97, ISR03092; ARC I2SR REFURB-SEKAT, 03M74-97, ISR03092; ARC I2SR REFURB-SEKAT, 03M74-97, ISR03092
• Patient Sex: Female