BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN HCG DIPSTICK 25T (URINE)

    MDR report key: 5955045 · Received September 15, 2016

    Report

    Report Number
    2027969-2016-00623
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 25, 2016
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TWO FALSE NEGATIVE HCG RESULTS ON THE SAME SPECIMEN FROM A PATIENT USING THE (B)(6) HCG DIPSTICK 25T (URINE). THE PREGNANCY WAS CONFIRMED BY A SERUM QUANTITATIVE HGC TEST, WHICH PRODUCED A POSITIVE RESULT OF APPROXIMATELY 500 MIU/ML. THE PATIENT'S LAST MENSTRUAL PERIOD WAS APPROXIMATELY 3 WEEKS PRIOR TO EVENT ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605205 HENRY SCHEIN HCG DIPSTICK 25T (URINE) HCG PREGNANCY TEST JHI FHC-101-KHS25 HCG5060116

    Patients

    Seq Age Sex Outcome Treatment
    1