BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 14335493 · Received May 9, 2022

    Report

    Report Number
    3005094123-2022-00096
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 21, 2022
    Report Date
    July 21, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 28417UD02 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT TOTAL B-HCG ASSAY FOR LOT 28417UD02 WAS IDENTIFIED. ADDITIONAL INFORMATION IN SECTION D3 EMAIL AND G1 MANUFACTURER SITE EMAIL

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON A 37-YEAR-OLD FEMALE PATIENT UNDERGOING IN VITRO FERTILIZATION. RESULTS PROVIDED: (B)(6) 2022= 126 MIU/ML, NEW SAMPLE ON (B)(6) 2022= <1.2 MIU/ML, DILUTION = < 7000 MIU/ML. ULTRASOUND REVEALED THE GESTATIONAL SAC HAS NOT BEEN DEVELOPING RECENTLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON A 37-YEAR-OLD FEMALE PATIENT UNDERGOING IN VITRO FERTILIZATION. RESULTS PROVIDED: (B)(6) 2022= 126 MIU/ML, NEW SAMPLE ON (B)(6) 2022= <1.2 MIU/ML, DILUTION = < 7000 MIU/ML. ULTRASOUND REVEALED THE GESTATIONAL SAC HAS NOT BEEN DEVELOPING RECENTLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840238 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 28417UD02

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)