BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSTAR OIA STREP B

    MDR report key: 1012565 · Received March 12, 2008

    Report

    Report Number
    1720655-2007-00001
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    April 1, 2007
    Report Date
    March 12, 2008
    Manufacturer
    INVERNESS MEDICAL-BIOSTAR INC
    Product Code
    GTY
    PMA / PMN Number
    k936112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL ASSESSMENT: DEVICE PERFORMED WITHIN SPECIFICATION (REFERENCE PACKAGE INSERT). IN CLINICAL TRIALS, OIA NEGATIVE 66% WHEN 24HR DIRECT CULTURE ALSO NEGATIVE, OIA POSITIVE 34% WHEN ONLY BROTH AMPLIFICATION POSITIVE. CLINICAL SPECIMEN MOST PROBABLY BELOW LIMIT OF DETECTION OF ASSAY. DEVICE EVALUATION (RETURNED & RETAINED DEVICES): UNABLE TO CONFIRM COMPLAINT; RETENTION DEVICES PERFORM WITHIN SPECIFICATION AT LIMIT OF DETECTION. RETURNED DEVICES SHOW SIGNIFICANT DAMAGE TO SURFACES, INCLUDING PRE-ASSAY SURFACES, MAKING LOW END INTERPRETATION DIFFICULT. HOWEVER, POSITIVE SIGNALS WERE OBTAINED WITH ONE COLONY FROM SWAB OF AGAR CULTURE AND WITH LOW/MODERATE STANDARDS. RETURNED DEVICES PERFORMED WITHIN RELEASE SPECIFICATIONS, BUT IT IS NOTED THAT SIGNIFICANT SURFACE DAMAGE NOT PRESENT ON RETAINED KIT MADE INTERPRETATION MORE DIFFICULT ON RETURNED DEVICES. SURFACE DAMAGE WAS NOT REPORTED AS A PART OF THE COMPLAINT, AND THE LAB IS PROFICIENT WITH OIA ASSAY. FOLLOW-UP WITH LAB INDICATED CONTROLS PERFORMED AS EXPECTED, NO SURFACE DAMAGE REPORTED. SURFACE DAMAGE MOST LIKELY OCCURRED DURING RETURN SHIPPING AND DID NOT CONTRIBUTE TO LAB'S NEGATIVE RESULT.

    Description of Event or Problem · 1

    LAB REPORTED MOTHER WAS SCREENED FOR GROUP B STREP USING THE BIOSTAR OIA STREP B ASSAY DURING LABOR. VAGINAL SPECIMEN WAS TAKEN ACCORDING TO DIRECTIONS FOR USE/PACKAGE INSERT. SEPARATE SPECIMEN WAS TAKEN FOR CULTURE. OIA RAPID ASSAY WAS NEGATIVE; NO PROPHYLACTIC ANTIBIOTIC WAS ADMINISTERED. INFANT DEVELOPED RESPIRATORY DISTRESS FOLLOWING BIRTH, AND DIED THE FOLLOWING DAY. AUTOPSY INDICATED GBS SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTAR OIA STREP B RAPID IMMUNOASSAY FOR GR. B STREP GTY INVERNESS MEDICAL-BIOSTAR INC * 176180

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Death