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

Model Number	07P5020
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A literature article by a.J.Kessler, et al., ¿discrepancies in estradiol levels in a premenopausal woman receiving abemaciclib despite ovarian function suppression and bilateral salpingo-oophorectomy¿, current problems in cancer: case reports 9 ( march 2023), presented a case of falsely elevated alinity i estradiol results for a 44-year-old premenopausal female who was diagnosed with clinical stage iii hr+ breast cancer.The following information was provided in the article.The patient was treated with neoadjuvant doxorubicin and cyclophosphamide every two weeks for four cycles followed by paclitaxel every two weeks for four cycles.The patient underwent a left mastectomy with a left axillary lymph node dissection as well as a prophylactic right mastectomy.The pathology revealed residual invasive poorly differentiated ductal carcinoma spanning 8 mm in greatest dimension in the breast tissue and three of ten lymph nodes with scattered foci of tumor in the background of treatment-related changes.The patient began monthly goserelin 3.6 mg followed by oral anastrozole 1 mg daily one month later.After two months of goserelin, the alinity i estradiol level was < 24 pg/ml (reference range for postmenopausal female: < 41 pg/ml).Following radiation therapy, the patient began adjuvant abemaciclib 150 mg twice daily.The patient continued to receive monthly goserelin and anastrozole.Two months after beginning abemaciclib, the alinity i estradiol increased to 68 pg/ml, at which time anastrozole was discontinued and started tamoxifen due to concern for failure of adequate ovarian function suppression (ofs).The following month, the patient underwent a laparoscopic bilateral salpingo-oophorectomy.Pathology confirmed removal of benign ovaries and fallopian tubes.The patient resumed anastrozole after surgery.Following surgery, estradiol levels continued to rise to a maximum level of 122 pg/ml three months after surgery.Anastrozole was again discontinued and the patient was resumed on tamoxifen while continuing abemaciclib.The patient was referred to endocrinology, at which time estradiol was rechecked by lc-ms testing with value of 2.2 pg/ml (reference range for postmenopausal female: < 15 pg/ml).It was noted that abemaciclib may have interfere with immunoassays.No further impact to patient management was reported.
Additional Manufacturer Narrative
Section e1 - facility name: (b)(6) institute.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Section e1 - email: email address was added.The complaint investigation for falsely elevated alinity i estradiol results included a review of data and information from the article ¿discrepancies in estradiol levels in a premenopausal woman receiving abemaciclib despite ovarian function suppression and bilateral salpingo-oophorectomy¿, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided in the article were reviewed and support the complaint issue.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 the product list number and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The assay instructions for use state that medications the patient was being treated with are known to interfere with alinity i estradiol.Therefore, this event is deemed incorrect use since the customer did not follow product labeling.Based on the investigation, the alinity i estradiol assay is performing as intended, no systemic issue or deficiency was identified.
Event or Problem Description
A literature article by a.J.Kessler, et al., ¿discrepancies in estradiol levels in a premenopausal woman receiving abemaciclib despite ovarian function suppression and bilateral salpingo-oophorectomy¿, current problems in cancer: case reports 9 (march 2023), presented a case of falsely elevated alinity i estradiol results for a 44-year-old premenopausal female who was diagnosed with clinical stage iii hr+ breast cancer.The following information was provided in the article.The patient was treated with neoadjuvant doxorubicin and cyclophosphamide every two weeks for four cycles followed by paclitaxel every two weeks for four cycles.The patient underwent a left mastectomy with a left axillary lymph node dissection as well as a prophylactic right mastectomy.The pathology revealed residual invasive poorly differentiated ductal carcinoma spanning 8 mm in greatest dimension in the breast tissue and three of ten lymph nodes with scattered foci of tumor in the background of treatment-related changes.The patient began monthly goserelin 3.6 mg followed by oral anastrozole 1 mg daily one month later.After two months of goserelin, the alinity i estradiol level was < 24 pg/ml (reference range for postmenopausal female: < 41 pg/ml).Following radiation therapy, the patient began adjuvant abemaciclib 150 mg twice daily.The patient continued to receive monthly goserelin and anastrozole.Two months after beginning abemaciclib, the alinity i estradiol increased to 68 pg/ml, at which time anastrozole was discontinued and started tamoxifen due to concern for failure of adequate ovarian function suppression (ofs).The following month, the patient underwent a laparoscopic bilateral salpingo-oophorectomy.Pathology confirmed removal of benign ovaries and fallopian tubes.The patient resumed anastrozole after surgery.Following surgery, estradiol levels continued to rise to a maximum level of 122 pg/ml three months after surgery.Anastrozole was again discontinued and the patient was resumed on tamoxifen while continuing abemaciclib.The patient was referred to endocrinology, at which time estradiol was rechecked by lc-ms testing with value of 2.2 pg/ml (reference range for postmenopausal female: < 15 pg/ml).It was noted that abemaciclib may have interfere with immunoassays.No further 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17133935
• Report Number: 3005094123-2023-00151
• Device Sequence Number: 6448652
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, 205UNKNOWN01; ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWN01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female