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 Type  malfunction  

Manufacturer Narrative

Customer reported that patient had been using interfering substances prior to sample collection.Customer was informed that topical medications can interfere with test performance as stated in the product package insert.No death, serious injury/illness or deterioration of health occured.Based on all clinical information available, patient was admitted and successfully delivered.Initial internal testing confirmed one false negative result and further investigation is pending.Customer results may have been affected by use of topical medications.In an abundance of caution this incident is being reported.The amnisure test is for use by healthcare professionals to aid in the diagnosis of rom in pregnant women reporting signs, symptoms or complaints suggestive of rom.Results should be used in conjunction with other clinical information and negative results alone may not rule out a membrane rupture.

Event Description

Customer reported false negative result for one patient that had used hydrocortizone and benzocaine at an unknown timeframe prior to testing.Patient was in active labor and successfully delivered 9 hours later.

• 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: 8559917
• MDR Text Key: 147463482
• Report Number: 1122376-2019-00001
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: 557017538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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