MAUDE Adverse Event Report: QIAGEN SCIENCES, LLC AMNISURE ROM TEST

Model Number FMRT-1

Device Problem False Negative Result (1225)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

This malfunction was found on one test strip that was returned by a customer for an unrelated investigation.It could not be reproduced on any retained test strips.Qiagen's overall evaluation does not indicated a systemic problem with false negatives in this lot.The performance is within the labeled characteristics of the product.Serious injuries are not likely if this malfunction were to recur.However, this report is being submitted in an abundance of caution.

Event Description

A false negative result was observed with one test strip during internal testing.

• Brand Name: AMNISURE ROM TEST
• Type of Device: AMNISURE ROM TEST
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• Manufacturer (Section G): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown 20874 ; 2406867876
• MDR Report Key: 7512913
• MDR Text Key: 108235955
• Report Number: 1122376-2018-00004
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: 557016546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1