BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ESTRADIOL

    MDR report key: 8363854 · Received February 22, 2019

    Report

    Report Number
    3005094123-2019-00041
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Report Date
    March 14, 2019
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3005094123-02/8/19-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOTS FOR SUSPECT MEDICAL DEVICE: FA05FEB2019 REVISION 01 NEW LOTS ADDED: ARCHITECT ESTRADIOL CATALOG= 07K72-25; UDI: (B)(4), LOTS: 87183UI00, DOM=31MAY2018, EXP=20FEB2019; 90177UI00 DOM= 18AUG2018, EXP= 17MAY2019; 93012UI00, DOM =11OCT2018, EXP=03JUL2019 CATALOG 07K72-35; UDI: (B)(4) LOTS: 87188UI00 DOM=23MAY2018, EXP=20FEB2019; 89230UI00, DOM=23MAY2018, EXP=20FEB2019; 91449UI00 DOM= 17JUL2018, EXP=18APR2019; 94069UI00 DOM=31OCT2018, EXP=15AUG2019 ALINITY I ESTRADIOL, CATALOG 07P50-20; UDI: (B)(4), LOTS: 90193UI00 DOM = 15AUG2018, EXP =17MAR2019, 96317UI00 DOM = 05FEB2019, EXP=02SEP2019 CATALOG 07P50-30, UDI: (B)(4), LOT 89235UI00 DOM =30JUL2018, EXP=18FEB2019.

    Additional Manufacturer Narrative · 1

    AN IN-HOUSE INVESTIGATION CONFIRMED THAT THE DRUG MIFEPRISTONE CAUSES INTERFERENCE/CROSS-REACTIVITY WITH THE ARCHITECT ESTRADIOL ASSAY LEADING TO FALSELY ELEVATED ESTRADIOL RESULTS. A PRODUCT CORRECTION LETTER WAS ISSUED ON 05FEB2019 TO ALL ARCHITECT ESTRADIOL AND ALINITY I ESTRADIOL CUSTOMERS WHO RECEIVED ONE OF THE LOTS LISTED BELOW. THE PRODUCT CORRECTION LETTER INFORMS THE CUSTOMER THAT PATIENTS UNDERGOING MIFEPRISTONE THERAPY SHOULD NOT BE TESTED WITH THE ARCHITECT ESTRADIOL OR THE ALINITY I ESTRADIOL ASSAYS FOR UP TO TWO WEEKS POST THEIR LAST DOSE. IT ALSO INSTRUCTS THE CUSTOMER TO REVIEW THE LETTER WITH THEIR MEDICAL DIRECTOR. THE ARCHITECT AND ALINITY ESTRADIOL PACKAGE INSERTS WILL BE UPDATED TO INCLUDE NEW INFORMATION REGARDING INTERFERENCE/CROSS-REACTIVITY BETWEEN THE ARCHITECT AND ALINITY ESTRADIOL ASSAYS AND THE DRUG MIFEPRISTONE. THIS CORRECTION INCLUDES THE FOLLOWING PRODUCTS FOR SUSPECT MEDICAL DEVICE: ARCHITECT ESTRADIOL: CATALOG 07K72-25; UDI = (B)(4), LOTS: 89225UI00, DATE OF MANUFACTURE (DOM) 17JUL2018 / EXPIRATION (EXP) 18APR2019; 91454UI00, DOM = 27SEP2018, EXP 03JUL2019; 93011UI00, DOM = 02OCT2018, EXP = 03JUL2019; 93537UI00, DOM = 23OCT2018, EXP = 18JUL2019; 94074UI00, DOM = 03NOV2018, EXP = 15AUG2019; 94285UI00, DOM = 05DEC2018, EXP = 10SEP2019; 95176UI00, DOM = 05JAN2019, EXP = 26SEP2019; 96316UI00 DOM = 30JAN2019, EXP = 02NOV2019. CATALOG 07K72-35; UDI = (B)(4), LOTS: 90185UI00, DOM= 08AUG2018, EXP = 17MAY2019; 93520UI00, DOM = 11OCT2018, EXP 18JUL2019; 94301UI00, DOM = 03DEC2018, EXP = 10SEP2019; 95196UI00, DOM = 04JAN2019, EXP = 26SEP2019; 96327UI00, DOM = 27JAN2019, EXP = 02NOV2019. ALINITY I ESTRADIOL: CATALOG 07P50-20; UDI = (B)(4), LOTS: 89177UI00, DOM = 26JUL2018, EXP = 18FEB2019; 91459UI00, DOM = 21OCT2018, EXP = 03MAY2019; 94291UI00, DOM = 07DEC2018, EXP = 10JUL2019; 95181UI00, DOM = 15JAN2019, EXP = 26JUL2019. CATALOG 07950-30; UDI = (B)(4), LOTS: 90198UI00, DOM = 16AUG2018, EXP = 17MAR2019; 91464UI00 DOM = 04NOV2018, EXP = 03MAY2019; 94079UI00 DOM = 13NOV2018, EXP = 15JUN2019; 95187UI00 DOM = 11JAN2019, EXP = 26JUL2019.

    Description of Event or Problem · 1

    ABBOTT HAS CONFIRMED THAT THE DRUG MIFEPRISTONE MAY INTERFERE / CROSSREACT WITH THE ARCHITECT ESTRADIOL ASSAY (LN 07K72) OR THE ALINITY I ESTRADIOL ASSAY (LN 07P50) WHICH MAY LEAD TO FALSELY ELEVATED ESTRADIOL RESULTS. THE POTENTIAL RISK TO HEALTH APPLIES ONLY TO PATIENTS BEING TREATED WITH THE DRUG MIFEPRISTONE WHICH MAY LEAD TO INCREASED ESTRADIOL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156177 ARCHITECT ESTRADIOL ESTRADIOL CHP A.I.D.D LONGFORD 87183UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY I INSTRUMENTS| ALINITY I INSTRUMENTS| ARCHITECT INSTRUMENTS| ARCHITECT INSTRUMENTS