BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 14566541 · Received June 1, 2022

    Report

    Report Number
    3005094123-2022-00111
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 5, 2022
    Report Date
    July 12, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    UDI-DI
    00380740014964
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL B-HCG REAGENT, LIST NUMBER 07K78-25, AND MANUFACTURING SITE IN SECTION D OF THIS REPORT, LONGFORD, TO ARCHITECT I2000SR, LIST NUMBER 03M74-02, AND MANUFACTURING SITE OF NEW SUSPECT DEVICE, IRVING. MDR NUMBER 3016438761-2022-00314-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. SECTION D3 EMAIL AND D1 EMAIL CORRECTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR FOUR PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: CASE 1: INITIAL RESULT 18.19 MIU/ML, REPEATED <1.20 MIU/ML CASE 2: INITIAL RESULT 19.89 MIU/ML, REPEATED <1.20 MIU/ML CASE 3: INITIAL RESULT 6.49 MIU/ML, REPEATED <1.20 MIU/ML CASE 4: INITIAL RESULT 14.91 MIU/ML, REPEATED <1.20 MIU/ML THE CUSTOMER REPORTED OUT THE <1.20 MIU/ML RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324616 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 7K78-25 35045UD00 00380740014964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, ISR61261| ARC I2000SR INST, 03M74-02, ISR61261