FDA Adverse Event Death Summary report: N

AMNISURE

MDR report key: 3873849 · Received June 9, 2014

Report

Report Number: 3005345832-2014-00004
Event Type: Death
Date Received: June 9, 2014
Report Date: June 9, 2014
Manufacturer: AMNISURE INTERNATIONAL, LLC
Product Code: NQM
PMA / PMN Number: K081767
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT THE RESULT OBTAINED FROM THE DEVICE DID NOT CONTRIBUTE OR CAUSE TO THE DEATH OF THE FETUS. HOWEVER, THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFO PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFO, AS NECESSARY. BASED ON THE INFO PROVIDED, IT IS UNCLEAR WHETHER THE TEST WAS NOT PERFORMED ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE. THE HEALTHCARE FACILITY REPORTED UNEXPECTED NEGATIVE RESULTS ALTHOUGH THE PT PRESENTED WITH NO AMNIOTIC FLUID PRESENT AND MINOR BLOOD. THE AMNISURE PRODUCT INSTRUCTIONS FOR USE STATES THAT A FALSE NEGATIVE MAY OCCUR WHEN A SAMPLE IS TAKEN 12 HOURS OR LATER AFTER A RUPTURE, DUE TO OBSTRUCTION OF THE RUPTURE BY THE FETUS OR RESEALING OF THE AMNIOTIC SAC.

Description of Event or Problem · 1

PT PRESENTED WITH MINOR BLOOD. THE FOLLOWING DAY ULTRASOUND SHOWED NO AMNIOTIC FLUID PRESENT AND PT WAS NOT REPORTING SIGNS/SYMPTOMS. FACILITY REPORTED THE FETUS DIED. AMNISURE TEST WAS NEGATIVE. FACILITY DID NOT INDICATE FURTHER DETAILS OF WHEN THE AMNISURE TEST WAS PERFORMED, THE GESTATIONAL AGE OF THE PT OR DETAILS OF SAMPLE TAKEN FOR THE AMNISURE TEST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
334327	AMNISURE	RAPID FETAL MEMBRANE RUPTURE TEST	NQM	AMNISURE INTERNATIONAL, LLC	FMRT-1	A2019

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death