BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG RAPID TEST

    MDR report key: 6046880 · Received October 21, 2016

    Report

    Report Number
    6046880
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 12, 2016
    Report Date
    October 18, 2016
    Manufacturer
    EKLA CORPORATION
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TECHNICIAN AT THIS FACILITY REPORTED TO A LABORATORY SUPERVISOR THAT TWO EVENTS OCCURRED INVOLVING INCORRECT HCG RESULTS. ACCORDING TO STAFF, THEY HAVE SEEN AN INCREASE OF SEVERAL INCORRECT HCG RESULTS IN THE PAST TWO WEEKS. THE RESULTS HAVE BEEN INCONSISTENT. THE SPECIFIC EVENTS THAT WERE REVIEWED WERE: AN EMERGENCY DEPARTMENT PATIENT TESTED POSITIVE WITH VPT-1 CASS, TWICE; SERUM TEST WAS NEGATIVE. PATIENT TESTED POSITIVE WITH A HOME PREGNANCY TEST, BUT HAD ONE POSITIVE AND ONE NEGATIVE RESULT WITH VPT1-CASS. THE LABORATORY SUPERVISOR CONTACTED THE MANUFACTURER TO DISCUSS THE EVENTS. THE IMMEDIATE ACTION TAKEN BY THE MANUFACTURER WAS TO SEND A REPLACEMENT SUPPLY VIA OVERNIGHT DELIVERY (ALL WITH DIFFERENT LOT NUMBERS THAN WHAT WE HAD IN OUR SUPPLY). THE MANUFACTURER COMPLETED AN INCIDENT REPORT REGARDING THE AFFECTED LOT NUMBER WITH FALSE POSITIVE RESULTS. THE MANUFACTURER SENT US THE VPT1-2-CASS URINE QUALITY CONTROL PROCEDURES THAT WE ARE TO FOLLOW WITH EACH NEW LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699934 HCG RAPID TEST HUMAN CHORIONIC GONADOTROPIN (HCG) PREGNANCY TEST DHA EKLA CORPORATION F606032

    Patients

    Seq Age Sex Outcome Treatment
    1