BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ESTRADIOL REAGENT KIT

    MDR report key: 21941035 · Received May 1, 2025

    Report

    Report Number
    3005094123-2025-00207
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CHP
    UDI-DI
    00380740014711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF COMPLAINT ACTIVITY FOR LOT 68273UD00 DID NOT IDENTIFY AN INCREASE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR LOT 68273UD00 IS COMPARABLE WITH OTHER LOTS IN THE FIELD CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF PRODUCT LABELING WAS PERFORMED WHICH PROVIDES APPROPRIATE INFORMATION RELATED TO THE CUSTOMER¿S ISSUE. BASED ON THE AVAILABLE INFORMATION, NO DEFICIENCY OF THE ARCHITECT ESTRADIOL ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL PATIENT ADDED ON (B)(6) 2025, SID (B)(6), (32-YR OLD FEMALE).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY A DECREASED ARCHITECT ESTRADIOL RESULT ON A 32-YR OLD FEMALE PATIENT THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 ARCHITECT = 434 PG/ML; ANOTHER LABORATORY (ELECTROCHEMILUMINESCENCE) = 520 PG/ML; ANOTHER LABORATORY (CHEMILUMINESCENCE) = 384 PG/ML; ANOTHER LABORATORY = 1029.30 PG/ML. ADDITIONAL PATIENT ADDED ON (B)(6) 2025: (B)(6) 2025 (32-YR OLD FEMALE) = SID (B)(6) = 434 PG/ML; ANOTHER LABORATORY = 384.00 PG/ML; ANOTHER LABORATORY = 1029.3 PG/ML; ANOTHER LABORATORY = 520.0 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT ESTRADIOL RESULT ON A 32-YR OLD FEMALE PATIENT THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 ARCHITECT = 434 PG/ML; ANOTHER LABORATORY (ELECTROCHEMILUMINESCENCE) = 520 PG/ML; ANOTHER LABORATORY (CHEMILUMINESCENCE) = 384 PG/ML; ANOTHER LABORATORY = 1029.30 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY A DECREASED ARCHITECT ESTRADIOL RESULT ON A 32-YR OLD FEMALE PATIENT THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 ARCHITECT = 434 PG/ML; ANOTHER LABORATORY (ELECTROCHEMILUMINESCENCE) = 520 PG/ML; ANOTHER LABORATORY (CHEMILUMINESCENCE) = 384 PG/ML; ANOTHER LABORATORY = 1029.30 PG/ML ADDITIONAL PATIENT ADDED ON (B)(6) 2025: (B)(6) 2025 (32-YR OLD FEMALE) = SID (B)(6) = 434 PG/ML; ANOTHER LABORATORY = 384.00 PG/ML; ANOTHER LABORATORY = 1029.3 PG/ML; ANOTHER LABORATORY = 520.0 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655614 ARCHITECT ESTRADIOL REAGENT KIT RADIOIMMUNOASSAY, ESTRADIOL CHP ABBOTT IRELAND DIAGNOSTICS DIVISION 68273UD00 00380740014711

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ARC I1SR REFURB-MEXICO, 01L86-84, (B)(6)| ARC I1SR REFURB-MEXICO, 01L86-84, (B)(6)