MAUDE Adverse Event Report: A.I.D.D LONGFORD 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	02/09/2022
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 suspects that falsely elevated alinity i estradiol results were generated for a female patient born in 1983.Repeatable elevated levels were measured multiple times (specific dates and values not provided) for a patient diagnosed with mammary cancer (estrogen-r +).Due to the elevated results, an adnexectomy (removal of fallopian tubes and ovaries) was performed as a therapeutic measure on (b)(6) 2022.There was no subsequent change in alinity i estradiol levels.Testing performed on (b)(6) 2022 generated an alinity i estradiol result of 107 pg/ml.Repeat testing at two other sites using an immunoassay and lc-ms/ms method generated negative results (exact values not provided).The patient was under continuous abemaciclib therapy (which is a known interferent for the alinity i estradiol assay) during the estradiol measurements.
Additional Manufacturer Narrative
Repeat positive estradiol results were obtained for one patient when negative results were expected.The patient had continuous cdk 4/6 inhibitor treatment during the estradiol measurements.The customer was using alinity i estradiol, reagent lot 35332ud00.The patient underwent an adnexectomy due to the elevated estradiol results, caused by cdk 4/6 interference.A review of the product quality history for the lot number using search of the corrective and preventive actions (capa) system did not identify issues associated with the customer¿s observation.Data and information provided by the customer were reviewed.From the review performed, it has been determined that there is sufficient labelling to aid the customer in troubleshooting this issue.No trends were identified.No elevated complaint activity was identified for lot 35332ud00.No non-statistical trend was observed.As per the alinity i estradiol package insert: this assay should not be used to assess estradiol levels for patients undergoing fulvestrant or mifepristone treatment.Structural and functional analogues of steroid hormones, including the estradiol molecule, have the potential to cause interference/cross reactivity with the alinity i estradiol assay.Samples from patients administered medications which inhibit tumor 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.The customer did not follow product labeling as required.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.A systemic issue and/or product deficiency was not identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• Brand Name: ALINITY I 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: 14949956
• Report Number: 3005094123-2022-00142
• Device Sequence Number: 4557766
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Expiration Date: 10/14/2022
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 35332UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 39 YR
• Patient Sex: Female