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

Model Number FMRT-1

Device Problem False Negative Result (1225)

Patient Problem Death, Intrauterine Fetal (1855)

Event Type  Death  

Manufacturer Narrative

The known information is as follows: patient at (b)(6) gestation presented at the hospital and was tested using amnisure.Blood was present in the sample.The amnisure result was negative.Amniotic fluid levels were determined to be increasing via afi, and patient was released from the hospital after an unspecified observation period.Sometime within a week (unspecified), the patient returned to the hospital and delivered prematurely, resulting in fetal death.Chorioamnionitis was present at the time of delivery.Further information has been requested from the customer.It is likely that the amnisure result was correct since other clinical testing and assessments also did not indicate rom.The amnisure test did not cause or contribute to the adverse event; however, in an abundance of caution, an mdr is being submitted.

Event Description

A report of a potential false negative amnisure result was received through a qiagen sales representative.A patient at (b)(6) gestation was tested with amnisure and another clinical method, both not indicating rom.Patient was admitted for observation and subsequently released.She returned to the hospital an unspecified number of days later and delivered prematurely, resulting in fetal death.

Manufacturer Narrative

This is a follow up report for mdr 1122376-2019-00002.After several attempts we are not able to obtain further information from the customer regarding this event.It appears that the test was used correctly in conjunction with other clinical tests and evaluations and that a decision was made to release the patient after an observation period based on the patient's whole clinical picture and subsequent to determining that the amniotic fluid levels were increasing.

• Brand Name: AMNISURE ROM TEST
• Type of Device: AMNISURE ROM TEST
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• MDR Report Key: 8609625
• MDR Text Key: 145032003
• Report Number: 1122376-2019-00002
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death