BIOSTAR RAPID GBS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-19 for BIOSTAR RAPID GBS * manufactured by Inverness Medical Professional Diagnosistics.

Event Text Entries

[17072907] The mother was admitted for an elective induction of labor at gestational age 37 5/7 weeks. The ob had not performed gbs cultures on the mother between 35-37 weeks choosing instead of utilize a biostar rapid test which was performed at admission. The specimen was taken only from the vagina apparently as the directions for the biostar test provide. A separate specimen was taken from the vagina as well and sent to the lab to culture. The biostar rapid test was negative for gbs and therefore the mother rec'd no gbs prophylaxis. The mother slowly labored the rest of the day without rupture of membranes and the ob decided to let the mother rest all night and the next day, cytotec was placed at around 8:30 am, then an epidural was placed at 11:00 am, and pitocin started at 1:30 pm and the ob ruptured the mother's membranes at 3:50 pm and the baby was delivered vaginally with a vacuum assist at 9:55 pm. Soon, the baby developed respiratory distress. The next day, at around 4:00 pm the baby died of gbs sepsis according to the autopsy. The culture on the mother's vag specimen grew gbs and the baby's blood culture grew gbs, however, too late as the baby had died. Nothing more that can be added.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5003807
• MDR Report Key: 917732
• Date Received: 2007-09-19
• Date of Report: 2007-09-19
• Date of Event: 2007-02-21
• Date Added to Maude: 2007-09-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOSTAR RAPID GBS
• Generic Name: BIOSTAR RAPID GBS
• Product Code: GTY
• Date Received: 2007-09-19
• Model Number: BIOSTAR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 890656
• Manufacturer: INVERNESS MEDICAL PROFESSIONAL DIAGNOSISTICS
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2007-09-19