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

Model Number 07P4830

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The customer questioned alinity i tsh results for one patient.The following was provided: (b)(6) - (b)(6) 2021 - initial result generated with tsh reagent lot 30385ud00 was 0.039 miu/l, new sample tested at a later date lid (b)(6) result 0.315 miu/l, new sample collected, tested and questioned however not provided by the customer.The results were reported out of the lab and were questioned by the physician.No impact to patient management was reported.

Manufacturer Narrative

Multiple sids were assigned to the same patient.No patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

An investigation was performed for alinity i tsh reagent lot 30385ud00.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 30385ud00 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 30385ud00 was identified.This event was additionally submitted via 3005094123-2022-00026 under a different suspected medical device lot.

• 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 N39 E-932 ; 433331157
• MDR Report Key: 13481255
• MDR Text Key: 287267332
• Report Number: 3005094123-2022-00027
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 07P4830
• Device Catalogue Number: 07P48-30
• Device Lot Number: 30385UD00
• 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: 09/01/2021
• 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, AI04435; ALNTY I PROCESSING MODU, 03R65-01, AI04435; ALNTY I TSH RGT 1200T K, 07P48-30, 30385UD00; ALNTY I TSH RGT 1200T K, 07P48-30, 30385UD00; ALNTY I TSH RGT 1200T K, 07P48-30, 35259UD00; ALNTY I TSH RGT 1200T K, 07P48-30, 35259UD00