BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK

    MDR report key: 2960997 · Received January 30, 2013

    Report

    Report Number
    2027969-2013-00104
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE URINE HCG RESULT WITH MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK VS. SERUM HCG RESULT. CUSTOMER STATES THEY HAD A PATIENT WHO TESTED HERSELF AT HOME ON THE EVENING OF (B)(6) 2013 AND OBTAINED A POSITIVE HCG RESULT. THE PATIENT RE-TESTED EARLY AM ON (B)(6) 2013 AND AGAIN RECEIVED A POSITIVE HCG RESULT. AT 11:45 AM THE PATIENT CAME INTO THEIR OFFICE FOR INJECTION OF A RADIOACTIVE ISOTOPE AND OBTAINED A NEGATIVE HCG RESULT. AT THE TIME THE RESULT CAME BACK NEGATIVE, THE PATIENT INFORMED THEM THAT SHE HAD RECEIVED 2 POSITIVE RESULTS AT HOME. AS A RESULT, THE PROCEDURE WAS NOT PERFORMED; THE PATIENT WAS NOT ADVERSELY AFFECTED. A SERUM WAS DRAWN AND THE HCG CAME BACK AT 872 MIU/ML. IT WAS DETERMINED THE PATIENT WAS 5-6 WEEKS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39988 MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK HCG PREGNANCY TEST JHI ALERE SAN DIEGO INC. FHC-111-OBN01 HCG2040006

    Patients

    Seq Age Sex Outcome Treatment
    1