BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)

    MDR report key: 6554029 · Received May 9, 2017

    Report

    Report Number
    1219913-2017-00117
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    March 23, 2017
    Report Date
    July 11, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00117 ON MAY 9, 2017. ON 06/13/2017 ADDITIONAL INFORMATION: THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER INTERNAL INVESTIGATION. NO INFORMATION IS KNOWN ABOUT MEDICATIONS OR SUPPLEMENTS TAKEN BY THE PATIENT. WHILE THE EXACT CAUSE OF THE FALSELY ELEVATED ESTRADIOL RESULTS CANNOT BE DETERMINED, A NON-SPECIFIC INTERFERENT CAN NOT BE RULED OUT. IMMUNOASSAYS ARE SUBJECT TO A NUMBER OF INTERFERENCES INCLUDING THOSE CAUSED BY ENDOGENOUS ANTIBODIES. INTERFERENCE CAN OCCUR BECAUSE OF HETEROPHILE ANTIBODIES, ANTI-ANIMAL ANTIBODIES AND AUTO ANTIBODIES. PATIENTS EXPOSED TO ANIMALS OR ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. THE INTERFERING ANTIBODIES CAN GIVE RISE TO A FALSELY HIGH OR LESS COMMONLY A FALSELY LOW RESULT. THE ERRONEOUS RESULT IS RECOGNIZED AS BEING INCONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. PLEASE NOTE THE INTERFERENT MAY NOT NECESSARILY BE DUE TO AN INTERFERING ANTIBODY BUT MAY BE DUE TO OTHER EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE CAUSE FOR THE ENHANCED ESTRADIOL (EE2) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE ENHANCED ESTRADIOL (EE2) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. THE CUSTOMER HAD TWO SAMPLES FROM THE SAME PATIENT AND TESTED THE SAMPLES ON THE ADVIA CENTAUR XP. THE RESULTS WERE HIGH. BOTH SAMPLES WERE TESTED ON THE ALTERNATE METHOD AND THE RESULTS WERE LOWER. THE CUSTOMER TESTED THE SAMPLE NEAT AND WITH HETEROPHILIC BLOCKING TUBE (HBT). THE NEAT RESULT WAS HIGHER THAN THE HBT RESULT. THE ALTERNATE METHOD RESULTS WERE CONSIDERED CORRECT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ENHANCED ESTRADIOL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334577 ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2) ENHANCED ESTRADIOL CHP SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 127035

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR