MAUDE Adverse Event Report: AMNISURE INTERNATIONAL, LLC AMNISURE; RAPID FETAL MEMBRANES RUPTURE TEST

Model Number FMRT-1

Device Problem False Negative Result (1225)

Patient Problem Septic Shock (2068)

Event Date 02/04/2015

Event Type  Injury  

Event Description

Patient arrived at the hospital on (b)(6) 2015.A visual exam of the vagina was completed; heavy yellow discharge was seen but no signs of amniotic fluid leakage.An amnisure test was performed and the result was negative.The patient was sent home.The patient returned to the hospital the net day and presented with a severe infection.Meconium was visible.The patient delivered and went into a septic shock.After delivery, the patient was placed in icu and administered antibiotics.The infant was also placed in nicu and administered antibiotics.Both patients recovered and were released from the hospital.

Manufacturer Narrative

The company has evaluated this event and has determined that the result obtained from the device did not contribute or cause a serious injury to the patient.The company is submitting this mdr for information purposes in compliance with 21 cfr 803.The company will supplement this mdr with additional information, as necessary.Based on the information provided, it is highly suspected that designated parts of the procedure and limitations of the test were not followed.The healthcare facility reported that they are actively correlating amnisure with another diagnostic test for tom.The other test has a 15 second collection requirement, whereas amnisure has a 60 second collection.A nurse at this facility admitted to performing 15 second collections for both tests.While it is unconfirmed what the collection time was for the specific patient in question, it is likely that the collection time was shortened due to confusion when running the tests one after another.Additionally, the healthcare facility reviewed the patient chart and believes it is possible the patient reported signs of rupture more than 12 hours prior to testing.

• Brand Name: AMNISURE
• Type of Device: RAPID FETAL MEMBRANES RUPTURE TEST
• Manufacturer (Section D): AMNISURE INTERNATIONAL, LLC; 24 school st.; 6th floor; boston MA 02108
• Manufacturer Contact: donna sowers ; 19300 germantown rd.; germantown, MD 20874 ; 2406867876
• MDR Report Key: 4589123
• MDR Text Key: 5337645
• Report Number: 3005345832-2015-00001
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: A353348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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): Life Threatening