BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID HCG URINE PREGNANCY CASSETTE

    MDR report key: 3243017 · Received July 18, 2013

    Report

    Report Number
    2027969-2013-00585
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE URINE HCG RESULT ON A PATIENT WHO WAS (B)(6) PREGNANT. THE CALLER STATED THAT A CUSTOMER OBSERVED A FALSE NEGATIVE RESULT FROM A URINE SAMPLE COLLECTED FROM A PATIENT WHO WAS THREE MONTHS PREGNANT. THE CUSTOMER STATED THAT THE PATIENT WAS TAKING SOME MEDICATIONS (NAMES OF MEDICATIONS NOT PROVIDED). THE CUSTOMER DID STATE THAT THE PATIENT'S SAMPLE WAS VERY TURBID AND ORANGE/RED IN COLOR. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335533 QUPID HCG URINE PREGNANCY CASSETTE HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-102-ONC44 HCG2040081

    Patients

    Seq Age Sex Outcome Treatment
    1