BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST

    MDR report key: 3023115 · Received February 26, 2013

    Report

    Report Number
    2027969-2013-00166
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE URINE HCG RESULTS WITH HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST THREE TIMES VS. POSITIVE ULTRASOUND RESULTS. CUSTOMER REPORTED THREE FEMALE PTS IN THEIR (B)(6) CAME INTO THE OFFICE TO CONFIRM HOME PREGNANCY TESTS. ALL THREE PTS HAD NEGATIVE RESULTS ON THE HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST. THE RESULTS WERE POSITIVE BY ULTRASOUND ON ALL THREE PTS. THESE PTS WERE ALL DETERMINED TO BE ABOUT (B)(6) PREGNANT WITH FETAL HEARTBEATS. NO DETAILED INFO WAS PROVIDED ABOUT THE PTS INCLUDING THE DATES OF THEIR LAST MENSTRUAL PERIODS. ALL THREE WERE TAKING PRENATAL VITAMINS. IT WAS ALSO STATED THAT NO TIMER WAS USED DURING THE TESTING AND TESTS WERE READ AT ABOUT ONE MINUTE RATHER THAN THE THREE MINUTES RECOMMENDED IN THE PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82816 HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO INC FHC-101-KHS25 HCG2010086

    Patients

    Seq Age Sex Outcome Treatment
    1