BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG DIPSTICK SP BRAND RAPID TEST

    MDR report key: 2820304 · Received October 31, 2012

    Report

    Report Number
    2027969-2012-01582
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE LOT NUMBER. UNABLE TO PERFORM FURTHER INVESTIGATION DUE TO INSUFFICIENT EVENT DETAILS. PT WAS ELEVEN (11) WEEKS PREGNANT AND MAY HAVE HIGH LEVELS OF HCG. HOOK EFFECT CANNOT RULED OUT. ROOT CAUSE CANNOT BE DETERMINED WITHOUT PT SPECIMEN ANALYSIS IN-HOUSE. THIS ISSUE WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE URINE HCG WITH CARDINAL HCG KIT VS. GUIDEL KIT RESULT. THE CUSTOMER TESTED A PT THAT WAS ELEVEN (11) WEEKS PREGNANT AND THE SP HCG CAME BACK NEGATIVE. THEY RAN A GUIDEL TEST AND IT CAME BACK A STRONG POSITIVE. NO OTHER INFO PROVIDED. TECHNICAL SUPPORT CALLED AND LEFT TWO MESSAGES FOR (B)(4). NO RESPONSE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCG DIPSTICK SP BRAND RAPID TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101-OBW01

    Patients

    Seq Age Sex Outcome Treatment
    1