BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE

    MDR report key: 2934907 · Received January 25, 2013

    Report

    Report Number
    2027969-2013-00084
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WITH MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE. CUSTOMER REPORTED A FALSE NEGATIVE URINE HCG RESULT WITH A MID-MORNING SAMPLE FROM ONE PT THAT WAS TESTED USING TWO DEVICES. THE CUSTOMER OBSERVED A NEGATIVE RESULT AT THE THREE MINUTE READ TIME BUT NOTICED THAT A FAINT LINE WAS SEEN AT FIVE OR SIX MINUTES. THE CUSTOMER THEN RAN THE SAME SAMPLE ON A DEVICE FROM A DIFFERENT BOX, (SAME LOT NUMBER) WITH THE SAME NEGATIVE RESULT. AFTER ABOUT 5 OR 6 MINUTES, THE CUSTOMER AGAIN NOTICED THAT THERE WAS A FAINT TEST LINE. THE PT THEN INFORMED THE CUSTOMER THAT HER HOME PREGNANCY TEST GAVE A POSITIVE RESULT. NO CONFIRMATION TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35903 MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202-OBW12 HCG2040284

    Patients

    Seq Age Sex Outcome Treatment
    1