BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG COMBO DEVICE SP BRAND RAPID TEST

    MDR report key: 2915411 · Received January 9, 2013

    Report

    Report Number
    2027969-2013-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WITH HCG COMBO DEVICE SP BRAND RAPID TEST. THE PT WAS 20+ YEARS OF AGE; FIRST URINE WAS TESTED ON (B)(6) 2012 AROUND 1 PM; HCG WAS NEGATIVE. SECOND TEST WAS DONE ON (B)(6) 2012, AROUND 11 AM, RESULT WAS NEGATIVE. LAST TEST WAS (B)(6) 2012 PER PT REQUEST BECAUSE SHE BELIEVED SHE WAS PREGNANT. TEST WAS PERFORMED AT 12 PM; RESULT WAS POSITIVE HCG. ON THE SAME DAY A SERUM QUANTITATIVE TEST WAS PERFORMED; RESULT WAS 9534 MIU/ML. ULTRASOUND INDICATED PT WAS 7-8 WEEKS PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12684 HCG COMBO DEVICE SP BRAND RAPID TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBW515 HCG2050021

    Patients

    Seq Age Sex Outcome Treatment
    1