BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 23474580 · Received November 5, 2025

    Report

    Report Number
    3005094123-2025-00556
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    January 1, 2022
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740014964
    PMA / PMN Number
    K983424
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE TICKET SEARCH DETERMINED THAT THERE IS NO INCREASE IN COMPLAINT ACTIVITY FOR THIS LIST NUMBER. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. INTERFERENCE BY HETEROPHILIC ANTIBODIES WAS CONFIRMED. ACCORDING TO THE PACKAGE INSERT HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. THE PRESENCE OF HETEROPHILIC ANTIBODIES IN A PATIENT SPECIMEN MAY DEMONSTRATE ANOMALOUS VALUES. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED AND THE PRODUCT IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 0

    AN ARTICLE BY JAROSLAV RACEK, IVANA POTOCOVÁ, DANIEL RAJDL, LADISLAV TREFIL, MARIE ¿OLCOVÁ. ¿FALSE POSITIVE RESULT OF HUMAN CHORIONIC GONADOTROPIN CAUSED BY HUMAN ANTI-MOUSE ANTIBODIES¿, BIOCHEM MED (ZAGREB) 2023;33(1):010802. THE STUDY NOTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS (1450 U/L) ON A 45-YEAR-OLD WOMAN THE PATIENT WAS SENT TO A REGIONAL HOSPITAL WITH THE DIAGNOSIS OF PREGNANCY OF UNKNOWN LOCALIZATION, TO EXCLUDE ECTOPIC PREGNANCY. HERE, DUE TO A SLIGHT DECREASE IN HCG CONCENTRATION, SHE UNDERWENT A REVISION OF HER UTERINE CAVITY WITH A NEGATIVE FINDING. AS THERE WAS ANOTHER SLIGHT DECREASE IN THE HCG CONCENTRATION THE NEXT DAY, THE UTERINE CAVITY REVISION WAS REPEATED AND SUPPLEMENTED WITH A LAPAROSCOPIC EXAMINATION WHERE THE GESTATIONAL SAC COULD NOT BE FOUND. THE PATIENT WAS THEN TRANSFERRED TO A UNIVERSITY HOSPITAL WHERE METHOTREXATE ADMINISTRATION WAS CONSIDERED. HOWEVER, BLOOD WAS FIRST DRAWN FOR HCG DETERMINATION: < 1 U/L (REAGENT KIT ELECSYS HCG+¿B, BASED ON ELECTROCHEMILUMINESCENCE (ECLIA), COBAS E602 ANALYZER (ROCHE DIAGNOSTICS) IN TWO DIFFERENT SAMPLES. ONE OF THE ABOVE-MENTIONED SAMPLES WAS THEN SENT TO TWO OTHER LABORATORIES TO OBTAIN RESULTS USING KITS FROM OTHER MANUFACTURERS. THE RESULTS WERE 2265 U/L ON AN ABBOTT ARCHITECT I1000SR AND 4.2 U/L USING REAGENT KIT ACCESS TOTAL BETA-HCG, BASED ON CHEMILUMINESCENCE (CLIA) ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (BECKMAN COULTER). THEREFORE, THE PRESENCE OF HETEROPHILIC ANTI-MOUSE ANTIBODIES WAS SUSPECTED. AFTER INCUBATION OF THE SAMPLE IN HETEROPHILIC BLOCKING TUBES, THE HCG RESULT WAS < 1.2 U/L ON AN ABBOTT ARCHITECT I1000SR. THEREFORE, PREGNANCY WAS RULED OUT, AND THE PATIENT WAS DISCHARGED TO HOME CARE. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    AN ARTICLE BY JAROSLAV RACEK, IVANA POTOCOVÁ, DANIEL RAJDL, LADISLAV TREFIL, MARIE ¿OLCOVÁ. ¿FALSE POSITIVE RESULT OF HUMAN CHORIONIC GONADOTROPIN CAUSED BY HUMAN ANTI-MOUSE ANTIBODIES¿, BIOCHEM MED (ZAGREB) 2023;33(1):010802. THE STUDY NOTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS (1450 U/L) ON A 45-YEAR-OLD WOMAN THE PATIENT WAS SENT TO A REGIONAL HOSPITAL WITH THE DIAGNOSIS OF PREGNANCY OF UNKNOWN LOCALIZATION, TO EXCLUDE ECTOPIC PREGNANCY. HERE, DUE TO A SLIGHT DECREASE IN HCG CONCENTRATION, SHE UNDERWENT A REVISION OF HER UTERINE CAVITY WITH A NEGATIVE FINDING. AS THERE WAS ANOTHER SLIGHT DECREASE IN THE HCG CONCENTRATION THE NEXT DAY, THE UTERINE CAVITY REVISION WAS REPEATED AND SUPPLEMENTED WITH A LAPAROSCOPIC EXAMINATION WHERE THE GESTATIONAL SAC COULD NOT BE FOUND. THE PATIENT WAS THEN TRANSFERRED TO A UNIVERSITY HOSPITAL WHERE METHOTREXATE ADMINISTRATION WAS CONSIDERED. HOWEVER, BLOOD WAS FIRST DRAWN FOR HCG DETERMINATION: < 1 U/L (REAGENT KIT ELECSYS HCG+B, BASED ON ELECTROCHEMILUMINESCENCE (ECLIA), COBAS E602 ANALYZER (ROCHE DIAGNOSTICS) IN TWO DIFFERENT SAMPLES. ONE OF THE ABOVE-MENTIONED SAMPLES WAS THEN SENT TO TWO OTHER LABORATORIES TO OBTAIN RESULTS USING KITS FROM OTHER MANUFACTURERS. THE RESULTS WERE 2265 U/L ON AN ABBOTT ARCHITECT I1000SR AND 4.2 U/L USING REAGENT KIT ACCESS TOTAL BETA-HCG, BASED ON CHEMILUMINESCENCE (CLIA) ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (BECKMAN COULTER). THEREFORE, THE PRESENCE OF HETEROPHILIC ANTI-MOUSE ANTIBODIES WAS SUSPECTED. AFTER INCUBATION OF THE SAMPLE IN HETEROPHILIC BLOCKING TUBES, THE HCG RESULT WAS < 1.2 U/L ON AN ABBOTT ARCHITECT I1000SR. THEREFORE, PREGNANCY WAS RULED OUT, AND THE PATIENT WAS DISCHARGED TO HOME CARE. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676742 ARCHITECT TOTAL B-HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740014964

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other ARC I1000SR MOD,01L86-01, SN# UNKNOWN.