MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	07P4820
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
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 observed a falsely decreased result for alinity i tsh and provided the following data (customer normal range is 0.45-4.50 uiu/ml): on (b)(6) 2023 sample id (b)(6) had an initial result of 0.19 and the customer reported that this sample was slightly hemolyzed.The patient was redrawn on (b)(6) 2023, sample id (b)(6), which had an initial result of 7.02.Both samples were repeated on (b)(6) 2023 and generated the following results: sid (b)(6)was 6.04 and sample id (b)(6) was 7.10.It was reported that the customer corrected the initial results of 0.19 and confirmed that the patient did not receive any treatment based upon the initial result.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased result of alinity i tsh reagent lot 40260ud04 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 field data review.Return testing was not completed as returns were not available.Ticket search by lot 40260ud04 indicates that the reagent lot performs as expected for this product.Ticket and trending review did not identify any trends regarding the complaint issue or the associated product list number.Device history record review for the associated product list number did not identify any issues associated with the complaint issue.The overall performance of the alinity i tsh reagents was reviewed using field data from customers worldwide.Review shows that the median patient result for lot 40260ud00 (the parent lot of 40260ud04) is comparable with other lots in the field confirming no systemic issue for the lot.A labeling reviewed determined product labeling provides appropriate information regarding resolving the issue the customer described.Based on the investigation, no systemic issue or deficiency with the alinity i tsh reagent lot 40260ud04 was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 16238317
• Report Number: 3005094123-2023-00018
• Device Sequence Number: 20446541
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K983442
• 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): 03/15/2023

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: 10/20/2023
• Device Model Number: 07P4820
• Device Catalogue Number: 07P48-20
• Device Lot Number: 40260UD04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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, AI21665; ALNTY I PROCESSING MODU, 03R65-01, AI21665
• Patient Sex: Unknown