BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST

    MDR report key: 2992927 · Received February 28, 2013

    Report

    Report Number
    2027969-2013-00170
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 28, 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 VS ULTRASOUND. CUSTOMER REPORTED A FEMALE PT CAME INTO THE OFFICE TO CONFIRM HOME PREGNANCY TEST. CUSTOMER OBSERVED A NEGATIVE RESULT WITH THE HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST. THE PT'S RESULTS WERE CONFIRMED BY ULTRASOUND AND FETAL HEARTBEAT; THE PT WAS DETERMINED TO BE ABOUT (B)(6) PREGNANT. NO PT INFO PROVIDED INCLUDING THE DATE OF THE PT'S LAST MENSTRUAL PERIOD. 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
    86247 HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101-KHS25 HCG2030054

    Patients

    Seq Age Sex Outcome Treatment
    1