BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE

    MDR report key: 3131490 · Received May 13, 2013

    Report

    Report Number
    2027969-2013-00385
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO INVESTIGATION CAN BE PERFORMED WITHOUT LOT NUMBER. CONCLUSION: PATIENT'S URINE SAMPLE WAS NOT A FIRST MORNING URINE. URINE MAY HAVE BEEN DILUTE DUE TO HYDRATION STATUS OR OTHER EXOGENOUS FACTORS. CUSTOMER DID NOT PROVIDED A LOT NUMBER. UNABLE TO PERFORM FURTHER INVESTIGATION TO DETERMINE ROOT CAUSE. THIS ISSUE WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS USING MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE IN COMPARISON TO A QUANTITIVE SERUM RESULTS OF 249 MIU/ML. PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) 2013. THE FIRST MORNING URINE WAS NOT USED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211722 MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-OBW12

    Patients

    Seq Age Sex Outcome Treatment
    1