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

Catalog Number 07K62-25

Device Problem Low Test Results (2458)

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

Event Date 11/25/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Initial reporter facility name: (b)(6).An evaluation is in-process.

Event Description

The customer generated a falsely decreased architect tsh result for a newborn patient (exact age unknown).The customer provided the following results: (b)(6) 2017: initial 0.003 uiu/ml.(b)(6) 2017: retest 1.53 uiu/ml.There was no adverse impact to patient management reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, device history record review, in-house testing, a search for similar complaints, and a review of labeling.Return material was not available from the customer.The device history record review did not identify any non-conformances or deviations.In-house accuracy test was performed using lot 79073ui00.The testing met acceptance criteria and the lot is performing within specifications.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect tsh reagent, ln 07k62, lot 79073ui00, was identified.

• Brand Name: ARCHITECT TSH
• Type of Device: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7134507
• MDR Text Key: 95921361
• Report Number: 3005094123-2017-00079
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Catalogue Number: 07K62-25
• Device Lot Number: 79073UI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1