BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 3643593 · Received February 24, 2014

    Report

    Report Number
    2024800-2014-00001
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    September 23, 2013
    Report Date
    February 21, 2014
    Manufacturer
    GEN-PROBE INCORPORATED
    Product Code
    LSL
    PMA / PMN Number
    K003395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT REPORTED TO BE DEFECTIVE.

    Description of Event or Problem · 1

    A LAB TECH REPORTED THAT HE SPLASHED SPECIMEN IN HIS EYE WHILE PIPETTING REAGENT PRIOR TO PERFORMING AN IN-VITRO DIAGNOSTIC ASSAY FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND/OR NEISSERIA GONORRHOEAE. THE SPECIMEN WAS IN THE TESTING TUBE, AND WHILE ADDING PROBE REAGENT, THE SPECIMEN SPLASHED INTO HIS EYE. THE LAB TECH WAS NOT WEARING GOGGLES AS IS REQUIRED BY INSTRUCTIONS IN THE PACKAGE INSERT FOR THIS ASSAY. THE LAB TECH DID NOT KNOW WHAT TYPE OF SPECIMEN IT WAS, IT COULD BE URINE OR MATERIAL FROM A VAGINAL COLLECTION. THE LAB TECH SOUGHT MEDICAL ATTENTION AND WAS GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113031 APTIMA COMBO 2 ASSAY IN-VITRO DIAGNOSTIC ASSAY LSL GEN-PROBE INCORPORATED 633593B

    Patients

    Seq Age Sex Outcome Treatment
    1 33 Required Intervention