BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 19859885 · Received July 30, 2024

    Report

    Report Number
    3005094123-2024-00396
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 19, 2024
    Report Date
    October 9, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163303
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 59328UD03, HOWEVER, NO RELATED TRENDS WERE IDENTIFIED REGARDING COMMONALITIES FOR COMPLAINT LOT NUMBER AND ISSUE. ADDITIONALLY, IN-HOUSE ACCURACY TESTING WAS COMPLETED, ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT WITH LOT 59328UD03 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOTAL B-HCG REAGENT LOT 59328UD03 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A RHEUMATOID PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 105.51 MIU/ML, REPEAT = 107.29 MIU/ML, ROCHE RESULT WAS <0.2 MIU/ML, URINE HCG WAS NEGATIVE. IT WAS NOTED THAT THE PATIENT¿S RF RESULTS WERE HIGH. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A RHEUMATOID PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 105.51 MIU/ML, REPEAT = 107.29 MIU/ML, ROCHE RESULT WAS <0.2 MIU/ML, URINE HCG WAS NEGATIVE. IT WAS NOTED THAT THE PATIENT¿S RF RESULTS WERE HIGH. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280894 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 59328UD03 00380740163303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)