BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 19429507 · Received May 30, 2024

    Report

    Report Number
    3005094123-2024-00290
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 25, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163303
    Adverse Event
    Yes
    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

    ADDITIONAL INFORMATION ADDED TO SECTION B5. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR COMPLAINT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. THE DISCREPANT RESULTS WERE NOT GENERATED FOR THE DETECTION OF EARLY PREGNANCY PER THE PRODUCT INTENDED USE. IN ADDITION, INTERFERENCE WAS INDICATED BASED ON PEG ANALYSIS RESULTS. PER PRODUCT LABELLING, SOME POTENTIAL REASONS FOR CONSISTENTLY ELEVATED HCG ARE THE PRESENCE OF NONSPECIFIC PROTEIN BINDING OR HCG-LIKE SUBSTANCES. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR ONE FEMALE PATIENT WHO WAS 42 DAYS POSTPARTUM. DUE TO ABNORMAL HCG RESULTS, A CLINICAL UTERINE CURETTAGE (D&C) WAS PERFORMED. THE PATIENT WAS GETTING SERIAL MEASUREMENTS FOR B-HCG. ON (B)(6), THE PATIENT¿S BLOOD HCG WAS TESTED. THE TEST RESULTS WERE ALL AROUND 120-130 MIU/ML. THE PATIENT CAME TO THE HOSPITAL TO DRAW BLOOD AND COLLECT A URINE SAMPLE. THE ARCHITECT TOTAL B-HCG RESULT ON (B)(6) 2024 WAS 122.04 MIU/ML (REFERENCE RANGE <5 MIU/ML IS NEGATIVE), BECKMAN RESULT WAS NEGATIVE, URINE SAMPLE WAS NORMAL. AFTER USING THE HETEROPHILIC ANTIBODY BLOCKING TUBE, THE SERUM HCG RESULT WAS STILL 106 MIU/ML. THE SAMPLE WAS PROCESSED USING PEG PRECIPITATION AND YIELDED A RESULT IN THE NORMAL RANGE. DUE TO ABNORMAL HCG RESULTS, A CLINICAL UTERINE CURETTAGE SURGERY (D&C) WAS PERFORMED (EXACT DATE UNKNOWN).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR ONE FEMALE PATIENT WHO WAS 42 DAYS POSTPARTUM. DUE TO ABNORMAL HCG RESULTS, A CLINICAL UTERINE CURETTAGE (D&C) WAS PERFORMED. THE PATIENT WAS GETTING SERIAL MEASUREMENTS FOR B-HCG. ON (B)(6), THE PATIENT¿S BLOOD HCG WAS TESTED. THE TEST RESULTS WERE ALL AROUND 120-130 MIU/ML. THE PATIENT CAME TO THE HOSPITAL TO DRAW BLOOD AND COLLECT A URINE SAMPLE. THE ARCHITECT TOTAL B-HCG RESULT ON (B)(6) 2024 WAS 122.04 MIU/ML (REFERENCE RANGE <5 MIU/ML IS NEGATIVE), BECKMAN RESULT WAS NEGATIVE, URINE SAMPLE WAS NORMAL. AFTER USING THE HETEROPHILIC ANTIBODY BLOCKING TUBE, THE SERUM HCG RESULT WAS STILL 106 MIU/ML. THE SAMPLE WAS PROCESSED USING PEG PRECIPITATION AND YIELDED A RESULT IN THE NORMAL RANGE. DUE TO ABNORMAL HCG RESULTS, A CLINICAL UTERINE CURETTAGE SURGERY (D&C) WAS PERFORMED (EXACT DATE UNKNOWN). UPDATE: THE PATIENT WAS REEXAMINED 42 DAYS AFTER DELIVERY, AND HCG WAS A MANDATORY EXAMINATION ITEM. THIS DATA WAS USED TO REFER TO WHETHER THERE WAS RESIDUE IN THE POSTPARTUM UTERUS. THE PATIENT IS NOT PREGNANT. DOCTORS NEED TO CONFIRM THE ACCURACY OF THE RESULTS, SO THEY REVIEW THEM MULTIPLE TIMES IN DIFFERENT PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258046 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 58182UD04 00380740163303

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Disability ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)