BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID HCG URINE PREGNANCY CASSETTE

    MDR report key: 1841549 · Received September 17, 2010

    Report

    Report Number
    2027969-2010-01496
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE URINE HCG RESULTS VS. QUANTITATIVE RESULTS. A PT CAME IN AND THEY RAN THE QUPID TEST 4X ON TWO DIFFERENT LOTS OF DEVICES (THE OTHER LOT IS A SEPARATE COMPLAINT). ALL RESULTS WERE NEGATIVE. DOCTOR STATED A FETAL HEARTBEAT WAS DETECTED AND PT WAS ESTIMATED TO BE (B)(6). THEY ALSO DID A QUANTITATIVE TEST ON AN IMMULYTE INSTRUMENT USING THE PT URINE. QUANT RESULT WAS >5000 MIU/ML (THIS IS THE UPPER LINEARITY LIMIT OF THE ANALYZER). SHE DILUTED THE URINE 1:10 AND RAN ON THE QUPID AND GOT A VERY STRONG POSITIVE RESULT. THE CUSTOMER ALSO NOTED THAT THEY HAD AT LEAST ONE OTHER FALSE NEGATIVE COMPLAINT ON LOT 32192.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUPID HCG URINE PREGNANCY CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-ONC44 32192

    Patients

    Seq Age Sex Outcome Treatment
    1