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

Model Number FMRT-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 12/13/2016

Event Type  Death  

Manufacturer Narrative

This event was not reported within 30 days because qiagen has information available that would enable a person who is qualified to make a medical judgment to reasonably conclude that the device did not cause or contribute to the adverse event.However, in an abundance of caution and in the interest of open communication, qiagen is providing an mdr report for this case due to the proximity of the test to a death, despite the absence of reasonable causation.

Event Description

On (b)(6) 2017 complaint #(b)(4) was reported of an unexpected negative result.Patient at (b)(6) (pre-viable) tested for rom and result was negative.Patient remained hospitalized under observation and 24 hours later a fetal death occurred just prior to or very soon after birth.Patient was diagnosed with infection of the fetal membranes and her wbc count was elevated.The nurse stated that the amnisure test result did not cause or contribute to the fetal death.The amnisure test was used as intended with other clinical information.

• 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: 7317815
• MDR Text Key: 101651951
• Report Number: 1122376-2018-00002
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: 551013472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death