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	01/06/2023
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.
Event or Problem Description
The customer observed falsely decreased alinity i tsh result for one patient when compared to the result from the main hospital.The sample was repeated, and the result was within normal range.The following data was provided: normal reference range is 0.35 to 4.94 uiu/ml.On (b)(6) 2023, sid: (b)(6), initial result (plasma sample) = < 0.0083 uiu/ml.On (b)(6) 2023, (main hospital; different draw) result = 2.369 uiu/ml.On (b)(6) 2023, sid: (b)(6), recentrifuged and repeated result = 1.3 uiu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased alinity i tsh result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot numbers 40260ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The overall performance of alinity i tsh reagents was reviewed using field data from customers worldwide.The median patient result for lot 40260ud00 is comparable with other lots in the field confirming no systemic issue for the lot.Based on this investigation, no systemic issue or deficiency with the alinity i tsh reagent, lot number 40260ud00 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: 16263296
• Report Number: 3005094123-2023-00022
• Device Sequence Number: 6066488
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 40260UD00
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2022
• 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, AI21884; ALNTY I PROCESSING MODU, 03R65-01, AI21884
• Patient Sex: Unknown