BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PLUS ONE STEP PREGNANCY TEST (URINE/SERUM)

    MDR report key: 1935638 · Received December 15, 2010

    Report

    Report Number
    2027969-2010-02176
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THIRD LOT NUMBER OF PRODUCT WAS ALSO PROVIDED BY THE CUSTOMER: HCG0010131. THE FOURTH LOT NUMBER TESTED ON THIS PT AND GIVING A FAINT POSITIVE RESULT WAS: HCG0050308. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE URINE HCG RESULT WHEN TESTING THREE DIFFERENT LOTS OF ELITE PLUS ONE STEP PREGNANCY TEST IN THEIR FACILITY. URINE FROM A (B)(6) FEMALE PT WAS TESTED WITH A NEGATIVE RESULT. CUSTOMER PROVIDED THREE DIFFERENT LOT NUMBERS, BUT WAS NOT ABLE TO PROVIDE DETAILS ABOUT WHICH LOTS MAY HAVE BEEN USED FOR THIS PT. A FOURTH LOT NUMBER WAS PROVIDED WHICH WAS USED FOR TESTING ON THIS PT'S URINE SAMPLE GIVING A FAINT POSITIVE RESULT. A SERUM QUANTITATIVE TEST WAS PERFORMED WITH A RESULT OF 183,681 MIU/ML. PHYSICIANS WERE ONLY PROVIDED WITH THE POSITIVE SERUM QUANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PLUS ONE STEP PREGNANCY TEST (URINE/SERUM) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC FHC-A202-OBC70 HCG0050333

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR