MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TSH

Catalog Number 07K62-25

Device Problem Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.

Event Description

The customer reported falsely decreased architect tsh results on one patient.The results provided were: (b)(6) 2018 tsh = 1.4 / (b)(6) 2018 = 0.2.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined there was not an increase in complaint activity for lot 85271ui00 and no trends were identified for the issue.Return testing was not completed as returns were not available.Accuracy testing was performed using a retained kit of lot number 85271ui00 and all testing met acceptance criteria.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for architect tsh, lot 85271ui00.

• Brand Name: ARCHITECT TSH
• Type of Device: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7841661
• MDR Text Key: 119041737
• Report Number: 3005094123-2018-00041
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2019
• Device Catalogue Number: 07K62-25
• Device Lot Number: 85271UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,; ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,; SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,; SERIAL # (B)(4)