BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSEETTE

    MDR report key: 3042310 · Received April 3, 2013

    Report

    Report Number
    2027969-2013-00274
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WITH THE (B)(4) PERFORMANCE HCG COMBO TEST-CASSETTE PREGNANCY TEST ON A FEW PTS. THE PTS WERE SEEN BY THEIR PHYSICIANS AND OBTAINED A POSITIVE TEST. ADDITIONALLY, THE CUSTOMER REPORTED THAT AN EMPLOYEE TOOK SEVERAL TESTS WITH THE MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE THAT WAS NEGATIVE. SHE THEN BOUGHT A TEST AT A LOCAL STORE A COUPLE HOURS LATER AND THAT RESULT WAS POSITIVE. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137349 MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSEETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202-OBW12 HCG2080113

    Patients

    Seq Age Sex Outcome Treatment
    1