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

Catalog Number	07P50-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
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 reported falsely elevated alinity i estradiol results on a breast cancer patient.The patient underwent adjuvant treatment for breast cancer including suppression of ovarian function.The lab testing consistently generated an estradiol result of about 100 pg/ml, suggesting the treatment was not effective.The patient underwent surgery to remove her ovaries to achieve the low estradiol levels.The mass spectrometry estradiol levels showed a discrepancy between the alinity i estradiol levels.Update: on (b)(6) 2024, additional patient information was provided by the customer.The customer states that the first time the patient generated estradiol results was in 2021.The most recent estradiol results were in 2023 ((b)(6), run on (b)(6) 2023 and (b)(6) run on (b)(6) 2023).The results were consistent with the 2023 data.However, the customer could not provide actual numerical values for these dates of testing.The customer could not provide any further additional information.There was no further adverse impact to patient management 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 within the article 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 alinity i 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 alinity i 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 alinity i estradiol assay was identified.
Event or Problem Description
The customer reported falsely elevated alinity i estradiol results on a breast cancer patient.The patient underwent adjuvant treatment for breast cancer including suppression of ovarian function.The lab testing consistently generated an estradiol result of about 100 pg/ml, suggesting the treatment was not effective.The patient underwent surgery to remove her ovaries to achieve the low estradiol levels.The mass spectrometry estradiol levels showed a discrepancy between the alinity i estradiol levels.Update: on (b)(6) 2024, additional patient information was provided by the customer.The customer states that the first time the patient generated estradiol results was in 2021.The most recent estradiol results were in 2023 ((b)(6), run on (b)(6) 2023 and (b)(6) run on (b)(6) 2023).The results were consistent with the 2023 data.However, the customer could not provide actual numerical values for these dates of testing.The customer could not provide any further additional information.There was no further adverse impact to patient management 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: 20338131
• Report Number: 3005094123-2024-00505
• Device Sequence Number: 20833002
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: (01)00380740129910
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 07P50-20
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown