BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSOM HCG URINE TEST

    MDR report key: 21107248 · Received January 8, 2025

    Report

    Report Number
    2030538-2025-00001
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 8, 2025
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JHI
    UDI-DI
    00742860001017
    PMA / PMN Number
    K974159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEST KIT IS NOT GOING TO BE RETURNED FOR INVESTIGATION. THE USER GUIDE FOR THE OSOM HCG URINE TEST RECOMMENDS THAT POSITIVE AND NEGATIVE EXTERNAL CONTROLS BE RUN WITH EACH NEW LOT AND WITH EACH NEW UNTRAINED OPERATOR. THE CUSTOMER INDICATED THAT THEY DID NOT PERFORM CONTROL TESTING ON THIS LOT PRIOR TO USE. A RETAIN KIT FOR OSOM HCG URINE TEST (PART NUMBER 101) LOT NUMBER 241012 WAS TESTED AND PERFORMED WITHIN TEST AND CONTROL LINE RELEASE SPECIFICATIONS FOR CONTROLS TESTED. THE NEGATIVE CONTROL PRODUCED A NEGATIVE RESULT AND THE POSITIVE CONTROL PRODUCED A POSITIVE RESULT. SEKISUI DID NOT FIND ANY PERFORMANCE DEFICIENCIES WITH THE OSOM HCG URINE TEST. THE DEFINITIVE CAUSE OF THE NOTED FALSE NEGATIVE RESULT DESCRIBED WITHIN THIS REPORT IS UNKNOWN. HOWEVER, AS SUMMARIZED IN THE LIMITATIONS IN THE IFU, THE ASSAY IS CAPABLE OF DETECTING ONLY WHOLE MOLECULE (INTACT) HCG BUT CANNOT DETECT HCG FRAGMENTS. LATER TERM PREGNANCIES BEYOND THE FIRST TRIMESTER MAY CONTAIN HIGH LEVELS OF HCG FRAGMENTS. THEREFORE, THE OSOM HCG URINE TEST IS MOST EFFECTIVE WHEN USED FOR THE DETECTION OF PREGNANCY IN ITS EARLIER STAGES.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT'S FIRST MORNING URINE WAS TESTED WITH AN OSOM HCG URINE TEST, AND THE RESULT WAS NEGATIVE. NO SERUM QUANTITATIVE HCG WAS PERFORMED. ON THE SAME DAY, THE PATIENT HAD AN ABDOMINAL SURGICAL PROCEDURE. A MASS WAS DISCOVERED DURING THE PROCEDURE WHICH TURNED OUT TO BE A THIRD TRIMESTER PREGNANCY. THE SURGERY WAS HALTED, AND THE PATIENT WAS ADMITTED TO HOSPITAL. ADDITIONAL DETAILS OF THE EVENT (SUCH AS WHICH PROCEDURE THE PATIENT HAD, PATIENT WEIGHT, ETC.) WERE NOT PROVIDED. DETAILS REGARDING THE OUTCOME OF THE PATIENT OR THE PREGNANCY WERE ALSO NOT PROVIDED. THE CUSTOMER STATED THEY HAD BEEN USING THE SAME LOT FOR SOME TIME, AND THAT THEY ARE A HIGH-VOLUME FACILITY (APPROX. 50 HCG PER DAY). THE FACILITY REPORTED NO OTHER FALSE NEGATIVES HAD BEEN OBTAINED USING THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910843 OSOM HCG URINE TEST HCG URINE PREGNANCY TEST KIT JHI SEKISUI DIAGNOSTICS, LLC 101 241012 00742860001017

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Hospitalization| O