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	12/15/2021
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.
Event or Problem Description
The customer observed falsely elevated alinity i estradiol results for one patient.The customer indicated that the wrong measurement together with other diagnostic indications led to the patient receiving an oophorectomy.Per the customer, ¿an oophorectomy was potentially performed due to the increased outcome and other factors¿.No further information has been received.The estradiol measurement together with other diagnostic indications led to the patient receiving an oophorectomy.
Additional Manufacturer Narrative
Field d4 lot number was updated.Additional information received.The female patient was receiving verzenios (abemaciclib) dosage 1st cycle 100 mg and is diagnosed with metastatic breast cancer.The initial alinity i estradiol result for sid (b)(6) was 267 pmol/l, sample was repeated on roche and the result was 20.5 pmol/l.Corrected data found in section g1 manufacturing office contact information.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.Device history record review was performed on lot number 29417ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.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.As per the 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 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.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.Corrected information found in section g1 manufacturer contact information.

• 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, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13174699
• Report Number: 3005094123-2022-00004
• Device Sequence Number: 14663886
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

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: 04/17/2022
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 29417UD00
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 02/04/2022; 04/07/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/24/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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). ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female