BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSTAR RAPID GBS

    MDR report key: 917732 · Received September 19, 2007

    Report

    Report Number
    MW5003807
    Event Type
    Death
    Date Received
    September 19, 2007
    Date of Event
    February 21, 2007
    Report Date
    September 19, 2007
    Manufacturer
    INVERNESS MEDICAL PROFESSIONAL DIAGNOSISTICS
    Product Code
    GTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTAR RAPID GBS BIOSTAR RAPID GBS GTY INVERNESS MEDICAL PROFESSIONAL DIAGNOSISTICS BIOSTAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Death