MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Model Number	07P5020
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier and date of event: (b)(6) 2021: sid not provided.(b)(6) 2021: sid 2104649381.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed alinity i estradiol result for two patients.The first patient is taking only fsh/lh hormonal injections.The following results were provided (lab expected range 10-649 pg/ml): (b)(6) 2021 sid (b)(6) initial result = (b)(6) pg/ml; repeat result on (b)(6) 2021 = >(b)(6) pg/ml and (b)(6) pg/ml (diluted).Progesterone : (b)(6) ng/ml.Lh : (b)(6) miu/ml.Fsh : (b)(6) miu/ml.Historical results for this patient were provided: (b)(6) 2021 sid (b)(6) result = 300.35 pg/ml.(b)(6) 2021 sid (b)(6) result = 44.83 pg/ml.(b)(6) 2021 sid (b)(6) result = 406.22 pg/ml.(b)(6) 2021 sid (b)(6) result = 1,367.16 pg/ml.(b)(6) 2021 sid (b)(6) result = 2,904.31 pg/ml.The customer stated this happened with a different patient on (b)(6) 2021, however no patient information was provided.Initial result = (b)(6) pg/ml; repeat result = (b)(6) pg/ml there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and inhouse testing of a retained kit of reagent lot 29016ud00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication of any additional issue.Ticket and trending review did not identify any trends for the likely cause lot.Device history review did not identify any non-conformances or deviations with the likely cause lot.Inhouse testing of the likely cause lot was completed.All validity and acceptance criteria were met demonstrating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i estradiol reagent lot 29016ud00 was identified.Corrected information in g1: contact office first name, contact office last name, contact office address 1, contact office address 2, contact office city, contact office country, contact office postal code, contact office phone number, contact office fax number, contact office e-mail.

• 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: 12860242
• Report Number: 3005094123-2021-00222
• Device Sequence Number: 4547053
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 29016UD00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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, AI03116; ALNTY I PROCESSING MODU, 03R65-01, AI03116
• Patient Sex: Unknown