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

Catalog Number	07K72-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
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 observed falsely elevated architect estradiol results on a 42-year-old female patient that resulted in a bilateral oophorectomy in (b)(6) 2023.The patient began taking abemaciclib for the treatment of right breast cancer t2n1 beginning in (b)(6) 2022.Additionally, the patient also concomitantly took adjuvant endocrine therapy.In (b)(6) 2023 the patient¿s architect estradiol results were 336 pmol/l.The physician switched the patient¿s adjuvant endocrine therapy, however, the estradiol results remained elevated.Due to the inadequate ovarian suppression, the patient underwent a bilateral oophorectomy in (b)(6) 2023.After the surgery, the patient¿s estradiol results remained elevated at 330 pmol/l.In (b)(6) 2024, the architect estradiol result was 500 pmol/l.The patient¿s endocrinologist had her estradiol levels tested at different hospitals with different platforms (roche, siemens, beckman) and they all generated the same result of <60 (unknown unit of measure).No additional/further impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated architect estradiol results on a 42-year-old female patient that resulted in a bilateral oophorectomy in (b)(6) 2023.The patient began taking abemaciclib for the treatment of right breast cancer t2n1 beginning in (b)(6) 2022.Additionally, the patient also concomitantly took adjuvant endocrine therapy.In (b)(6) 2023 the patient¿s architect estradiol results were 336 pmol/l.The physician switched the patient¿s adjuvant endocrine therapy, however, the estradiol results remained elevated.Due to the inadequate ovarian suppression, the patient underwent a bilateral oophorectomy in (b)(6) 2023.After the surgery, the patient¿s estradiol results remained elevated at 330 pmol/l.In (b)(6) 2024, the architect estradiol result was 500 pmol/l.The patient¿s endocrinologist had her estradiol levels tested at different hospitals with different platforms ((b)(6)) and they all generated the same result of <60 (unknown unit of measure).No additional/further impact to patient management was reported.
Additional Manufacturer Narrative
Section h1 type of reportable event was updated from malfunction to serious injury.Section h11 additional mfg narrative was updated due to a typographical correction.The complaint investigation included a review of data and information provided within the article, 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.The ticket trending review did not identify any trends for the issue for the product.An additional sub search for similar complaints could not be performed as the lot number was unknown.Labeling was reviewed and sufficiently addresses the customer¿s issue.Per product labeling, samples from patients administered medications which inhibit tumour cell proliferation (e.G.Cdk 4/6 inhibitors) may be subject to interference/cross reactivity with the architect estradiol assay.In addition, drugs which interfere with or activate production of steroid hormones (e.G.Aromatase inhibitors) may also interfere or cross react with the architect estradiol assay.In such cases, an alternate method such as chromatography should be used.In this case, the assay should not have to been used to test estradiol levels of patients undergoing treatment with abemaciclib as it is a known interferent.Based on the investigation the architect estradiol is performing as intended, no systemic issue or deficiency of the architect estradiol assay was identified.
Event or Problem Description
The customer observed falsely elevated architect estradiol results on a 42 year old female patient that resulted in a bilateral oophorectomy in (b)(6) 2023.The patient began taking abemaciclib for the treatment of right breast cancer t2n1 beginning in (b)(6) 2022.Additionally, the patient also concomitantly took adjuvant endocrine therapy.In (b)(6) 2023 the patient¿s architect estradiol results were 336 pmol/l.The physician switched the patient¿s adjuvant endocrine therapy, however, the estradiol results remained elevated.Due to the inadequate ovarian suppression, the patient underwent a bilateral oophorectomy in (b)(6) 2023.After the surgery, the patient¿s estradiol results remained elevated at 330 pmol/l.In (b)(6) 2024, the architect estradiol result was 500 pmol/l.The patient¿s endocrinologist had her estradiol levels tested at different hospitals with different platforms (roche, siemens, beckman) and they all generated the same result of <60 (unknown unit of measure).No additional/further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided within the article, 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.The ticket trending review did not identify any trends for the issue for the product.An additional sub search for similar complaints could not be performed as the lot number was unknown.Labeling was reviewed and sufficiently addresses the customer¿s issue.Per product labeling, samples from patients administered medications which inhibit tumour cell proliferation (e.G.Cdk 4/6 inhibitors) may be subject to interference/cross reactivity with the architect estradiol assay.In addition, drugs which interfere with or activate production of steroid hormones (e.G.Aromatase inhibitors) may also interfere or cross react with the architect estradiol assay.In such cases, an alternate method such as chromatography should be used.In this case, the assay should not have to been used to test estradiol levels of patients undergoing treatment with abemaciclib as it is a known interferent.Based on the investigation the alinity i estradiol is performing as intended, no systemic issue or 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: 20415693
• Report Number: 3005094123-2024-00520
• Device Sequence Number: 8202778
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: (01)00380740014711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07K72-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 11/01/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/04/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 42 YR
• Patient Sex: Female