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

Model Number 07P4820

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

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 Description

The customer stated that a falsely depressed alinity i tsh result of 0.08 miu/ml was generated for a patient sample (id (b)(4)) on (b)(6) 2021.The sample cup was insufficiently filled with sample volume, and the falsely depressed result was generated without any error message.A different sample from the same patient with adequate sample volume generated a tsh result of 1.006 miu/ml using the architect i2000 method.No adverse impact to patient management was reported.

Event Description

The customer stated that a falsely depressed alinity i tsh result of 0.08 miu/ml was generated for a patient sample ((b)(6)) on (b)(6) 2021.The sample cup was insufficiently filled with sample volume, and the falsely depressed result was generated without any error message.A different sample from the same patient with adequate sample volume generated a tsh result of 1.006 miu/ml using the architect i2000 method.No adverse impact to patient management was reported.

Manufacturer Narrative

Trending review determined no adverse trend for the issue for the product.Historical complaint review by lot indicates that the reagent lot performs as expected for this product.Device history record review did not show any potential non-conformances or deviations.Labelling was reviewed and found to adequately address the issue under review.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency for lot number 30389ud00 was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: 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 ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12969590
• MDR Text Key: 286507228
• Report Number: 3005094123-2021-00241
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 07P4820
• Device Catalogue Number: 07P48-20
• Device Lot Number: 30389UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI01588.; ALNTY I PROCESSING MODU, 03R65-01, AI01588.