BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 4182416 · Received October 17, 2014

    Report

    Report Number
    2024800-2014-00003
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 17, 2014
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    LSL
    PMA / PMN Number
    K003395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE LAB TECH REPORTED THAT SHE SPLASHED SOLUTION CONTAINED IN THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION TUBE INTO HER EYES. AS SHE WAS PIPETTING THE URINE INTO THE SPECIMEN COLLECTION TUBE WITH THE PROVIDED PIPET, THE TRANSPORT MEDIA RAISED AND BUBBLED UP AND A BUBBLE POPPED CLOSE TO HER FACE. IT WAS NOTED THAT SHE IS SHORT IN STATURE AND THEREFORE WAS CLOSE TO THE TUBE. THE LAB TECH WAS NOT WEARING GOGGLES AS IS REQUIRED BY INSTRUCTION IN THE PACKAGE INSERT FOR THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION KIT, BUT WAS WEARING GLOVES AND A LAB COAT. AFTER THE EVENT, THE LAB TECH FLUSHED HER EYES WITH WATER AND WENT TO THE ER AND WAS PRESCRIBED ANTIBIOTICS. ACCORDING TO THE SAFETY DATA SHEET FOR THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION KIT, THE SOLUTION IS NOT CONSIDERED HAZARDOUS BY THE 2012 OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661522 APTIMA COMBO 2 ASSAY IN-VITRO DIAGNOSTIC ASSAY LSL HOLOGIC INCORPORATED 108724A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention