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

Model Number 07P4830

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple patient identifiers are used for multiple samples of the same patient; refer for summary of sids and associated results.No patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer identified falsely depressed alinity i tsh results for one patient.The following was provided on (b)(6) 2021 sid (b)(6) result 0.08 miu/l; previous sample sid (b)(6) 0.354 miu / l no impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for alinity i tsh reagent lot 35252ud00.A review of tickets was performed and determined the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing for reagent lot: 35252ud00 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 lots are performing acceptably.A review of the product quality history for the lot number using search of the corrective and preventive actions (capa) system did not identify issues associated with the customer¿s observation.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity i tsh reagent lot 35252ud00.D4 catalogue number was corrected to 07p48-20.H6 medical device problem code corrected to a090810 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 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 ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13108873
• MDR Text Key: 282904209
• Report Number: 3005094123-2021-00257
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 07P4830
• Device Catalogue Number: 07P48-20
• Device Lot Number: 35252UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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