BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERIFYNOW P2Y12 TEST DEVICE

    MDR report key: 2640626 · Received June 20, 2012

    Report

    Report Number
    2031760-2012-00001
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    April 12, 2012
    Report Date
    June 20, 2012
    Manufacturer
    ACCUMETRICS
    Product Code
    JOZ
    PMA / PMN Number
    K051231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FINGER STICK TO AN EXPOSED VERIFYNOW TEST DEVICE NEEDLE. AFTER TESTING THE TECH INITIALLY THREW OUT THE INTACT VACUTAINER/TEST DEVICE INTO THE MEDICAL WASTE CONTAINER PER THE PACKAGE INSERT INSTRUCTIONS. LATER IN AN ATTEMPT TO RESOLVE A TEST DISCREPANCY, TECH RETRIEVED THE INTACT TEST DEVICE / VACUTAINER FROM THE MEDICAL WEST CONTAINER AND REMOVED THE VACUTAINER FROM THE TEST DEVICE. AFTER THE TECH REMOVED THE VACUTAINER FROM THE TEST DEVICE AND RESOLVED THE DISCREPANCY, THE TECH WENT TO THROW OUT THE SEPARATED TEST DEVICE AND VACUTAINER AND INADVERTENTLY INSERTED A FINGER INTO THE SAMPLE WELL OF THE TEST DEVICE WHERE THE NEEDLE IS HOUSED. DEVICE NEEDLE EXPOSURE (FINGER STICK) OCCURRED AFTER TECH REMOVED SAMPLE VACUTAINER VIAL FROM DEVICE SAMPLE WELL. WOUND WAS TREATED BY THOROUGH CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFYNOW P2Y12 TEST DEVICE JOZ ACCUMETRICS WL0113

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention