BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 16627519 · Received March 28, 2023

    Report

    Report Number
    3005094123-2023-00077
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 18, 2023
    Report Date
    June 14, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    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

    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. THE TICKET SEARCH DETERMINED THAT THERE IS HIGHER COMPLAINT ACTIVITY FOR THIS LOT NUMBER BUT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. THE OVERALL PERFORMANCE OF ARCHITECT TOTAL SS-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED VIA ABBOTTLINK FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO THE CUT-OFF AND THE MEDIAN OF THE NEGATIVE POPULATIONS IS WITHIN THE ESTABLISHED LIMITS AND WITHIN THE HISTORICAL RANGE OF THE ARCHITECT TOTAL B-HCG ASSAY. ADDITIONALLY, ACCURACY OF THE ARCHITECT TOTAL B-HCG ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 42508UD01 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ARCHITECT TOTAL B-HCG PRODUCT REQUIREMENTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL B-HCG LOT# 42508UD01.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT ON A 22-YR OLD FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2023 = 40.44 IU/L, (B)(6) 2023 NEGATIVE ON ANOTHER PLATFORM, REPEATED INITIAL SAMPLE ON ARCHITECT = 11.31 IU/L, RE-CENTRIFUGED SAMPLE = 1.20 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT ON A 22-YR OLD FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2023 = 40.44 IU/L, (B)(6) 2023 NEGATIVE ON ANOTHER PLATFORM, REPEATED INITIAL SAMPLE ON ARCHITECT = 11.31 IU/L, RE-CENTRIFUGED SAMPLE = < 1.20 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9696 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 42508UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)