BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY

    MDR report key: 6933518 · Received October 9, 2017

    Report

    Report Number
    1524213-2017-00002
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 29, 2017
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Product Code
    NJR
    UDI-DI
    00840733101342
    PMA / PMN Number
    K121044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL QUALITY CONTROL TESTING DOCUMENTATION REVIEW COMPLETED; PRODUCT RELEASE SPECIFICATIONS WERE SATISFIED. CERTIFICATE OF ANALYSIS ISSUED MAY 04, 2017. EVALUATION OF RETAIN KIT FROM SAME LOT COMPLETED ON 09/07/2017. RETAIN KIT TESTING PERFORMED USING QUALIFIED QUALITY CONTROL POSITIVE SPECIMENS. REPORTED POSITIVE CONTROL RESULTS WERE AS EXPECTED. TRENDING COMPLAINT REVIEW COMPLETED BY TECHNICAL SUPPORT PERSONNEL. NO OTHER FALSE POSITIVE COMPLAINTS REPORTED FOR LOT NUMBER 20350J052. THIS IS THE FIRST REPORTED COMPLAINT FOR LOT NUMBER 280350J052. EVENT MAINTAINED IN MERIDIAN BIOSCIENCE, INC. CUSTOMER COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A (B)(6) OLD BABY CAME TO ((B)(6) HOSPITAL) ED WITH FEVER. SPINAL TAP AND BLOOD CULTURES WERE DRAWN. CSF AND BLOOD CULTURE WERE POSITIVE FOR GROUP B STREP. BABY WAS TRANSFERRED TO (B)(6) NEONATAL ICU AND WAS ON VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710749 ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS NJR MERIDIAN BIOSCIENCE, INC. 280350 280350J052 00840733101342

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Life Threatening