BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 3082604 · Received April 23, 2013

    Report

    Report Number
    2027969-2013-00330
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A NEGATIVE RESULT ON A POSITIVE PT FOR ICON 25. CUSTOMER STATED SAMPLE USED FOR TEST DEVICE WAS URINE. THE BHCG WAS 203. CUSTOMER STATED PT HAD ECTOPIC PREGNANCY AND ON METHOTREXATE. ICON 25 LOT # 2030365 EXP. 03/2014. TEST KITS ARE KEPT AT ROOM TEMPERATURE. PT CARE WAS NOT AFFECTED. CONFIRMATION WAS BASED ON SERUM QUANTITATIVE BHCG. CUSTOMER STATED INSTRUCTIONS WERE FOLLOWED PER PACKAGE INSERT. CUSTOMER STATED PER STAFF THAT RAN TEST CONTROL LINE WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174701 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC 202 HCG2030365

    Patients

    Seq Age Sex Outcome Treatment
    1