BEUDAMED
    FDA Adverse Event Summary report: N

    CLINITEK STATUS+

    MDR report key: 4223342 · Received November 4, 2014

    Report

    Report Number
    1217157-2014-00167
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K032563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER SIEMENS INVESTIGATION DATA, TWO CASSETTES WERE RUN WITH THE PATIENT'S URINE AND OBTAINED NEGATIVE RESULTS. THE URINE AND SERUM WERE SENT OUT FOR IMMULITE TESTING IN SIEMENS LA. THE RESULTS CAME BACK NEGATIVE FOR URINE (6.61 MIU) AND POSITIVE FOR SERUM (79.08 MIU). WITH THIS SMALL HCG NEGATIVE CONCENTRATION IN URINE, A FAINT LINE MIGHT APPEAR WHICH WE SAW, BUT WAS NOT AS DARK AS THE 25 MIU REFERENCE LINE RESULTING IN A NEGATIVE RESULT. THE SIEMENS IMMULITE IS VALIDATED FOR URINE AND DETECTS THE MOST VARIANTS OF ALL IMMUNOCHEMISTRY ANALYZERS. THE URINE IMMULITE RESULTS MATCH THE NEGATIVE RESULTS THE CUSTOMERS CLINITEK STATUS INSTRUMENT REPORTED. THE IMMULITE ALSO MATCHED THE SERUM RESULTS OBTAINED FROM THE CUSTOMER WHICH WAS POSITIVE (79.08 MIU IMMULITE AND 64 MIU SIEMENS DIMENSION). IT APPEARS THERE WAS POSSIBLY HETEROPHILIC ANTIBODIES THAT WERE IN THE SERUM THAT WERE NOT IN THE URINE. A REFERENCE REGARDING HETEROPHILIC ANTIBODIES WHEREBY THE SERUM CAN GIVE FALSE POSITIVE RESTS WAS PUBLISHED STATING: A URINE TEST (EITHER QUANTITATIVE OR QUALITATIVE) FOR HCG CAN BE PERFORMED. BECAUSE HETEROPHILIC ANTIBODIES ARE NOT PRESENT IN URINE, IF THE URINE TEST RESULT IS NEGATIVE AND THE SERUM TEST RESULT IS PERSISTENTLY POSITIVE, INTERFERENCE IN THE SERUM IMMUNOASSAY IS CONFIRMED IF THE SERUM VALUE IS >=50 MIU/ML (3). REFERENCE: ROTMENSCH S, COLE LA. FALSE DIAGNOSIS AND NEEDLESS THERAPY OF PRESUMED MALIGNANT DISEASE IN WOMEN WITH FALSE-POSITIVE HUMAN CHORIONIC GONADOTROPIN CONCENTRATIONS. LANCET 2000;355:712-5.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707895 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1