BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ESTRADIOL

    MDR report key: 5621150 · Received April 29, 2016

    Report

    Report Number
    3005094123-2016-00022
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    December 1, 2015
    Report Date
    April 29, 2016
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CHP
    Removal / Correction Number
    3005094123-03/25/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT). (B)(4) (HIGH TEST RESULTS). IN-HOUSE INVESTIGATION CONFIRMED THAT THE DRUG FULVESTRANT CAUSES INTERFERENCE/CROSS-REACTIVITY WITH THE ARCHITECT ESTRADIOL ASSAY LEADING TO FALSELY ELEVATED ESTRADIOL RESULTS. A PRODUCT CORRECTION LETTER WAS ISSUED TO ALL CURRENT ARCHITECT ESTRADIOL CUSTOMERS. THE LETTER INFORMS THE CUSTOMER THAT PATIENTS UNDERGOING FULVESTRANT THERAPY SHOULD NOT BE TESTED WITH THE ARCHITECT ESTRADIOL ASSAY. IT ALSO INSTRUCTS THE CUSTOMER TO REVIEW THE LETTER WITH THEIR MEDICAL DIRECTOR. THE ARCHITECT ESTRADIOL PACKAGE INSERT WILL BE UPDATED TO INCLUDE NEW INFORMATION REGARDING INTERFERENCE/CROSS-REACTIVITY BETWEEN THE ARCHITECT ESTRADIOL ASSAY AND THE DRUG FULVESTRANT.

    Description of Event or Problem · 1

    THE CUSTOMER INQUIRED REGARDING POTENTIAL INTERFERENCE (FALSELY ELEVATED RESULTS) WITH THE ARCHITECT ESTRADIOL ASSAY FOR A FEMALE PATIENT, BORN ON (B)(6) 1972, WHO HAS BEEN TAKING FASLODEX SINCE (B)(6) 2015. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE FOLLOWING ARCHITECT ESTRADIOL RESULTS WERE PROVIDED: (B)(6) 2015: 14 NG/L; (B)(6) 2015: 10 NG/L; (B)(6) 2015: 47 NG/L; (B)(6) 2015: 71 NG/L; (B)(6) 2015: 48 NG/L; (B)(6) 2016: 57 NG/L; (B)(6) 2016: 89 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276308 ARCHITECT ESTRADIOL ESTRADIOL CHP A.I.D.D LONGFORD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR