BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 16104650 · Received January 5, 2023

    Report

    Report Number
    3005094123-2023-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 17, 2022
    Report Date
    February 22, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    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

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 42508UD01, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. AS PER THE INTENDED USE SECTION OF THE PACKAGE INSERT (7K78, G6-5495/ R15, B7K780): ¿THE ARCHITECT TOTAL -HCG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF BETA HUMAN CHORIONIC GONADOTROPIN (-HCG) IN HUMAN SERUM AND PLASMA FOR THE EARLY DETECTION OF PREGNANCY.¿ THE ASSAY IS NOT INTENDED TO MONITOR FETAL DEVELOPMENT, THEREFORE THERE WAS AN ABNORMAL USE OF THE ASSAY. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TOTAL SS-HCG ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TOTAL B-HCG RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: 35-YEAR-OLD, IN VITRO FERTILIZATION, 8 WEEKS PREGNANT, ARCHITECT TOTAL B-HCG RESULT ON (B)(6) 2022 WAS 13687 MIU/ML, AND ARCHITECT TOTAL B-HCG RESULT ON (B)(6) 2022 WAS 14183 MIU/ML. SINCE THE PATIENTS¿ ARCHITECT TOTAL B-HCG RESULTS DID NOT ELEVATE, THE CLINICAL PHYSICIAN PRESCRIBED MEDICATION TO PREVENT MISCARRIAGE. ADMINISTRATION OF THIS TREATMENT MEDICATION WAS CONSIDERED TO BE UNNECESSARY. THE CUSTOMER SWITCHED TO A NEW CALIBRATOR AND RETESTED THE (B)(6) 2022 SAMPLES. PATIENT 1¿S UNDILUTED HCG RESULT WAS GREATER THAN 15000 MIU/ML, AND THE DILUTED RESULT WAS 142564 MIU/ML. THE PATIENT IS IN GOOD HEALTH AND THERE WAS NO HARM TO THE FETUS. IN ORDER TO CONFIRM THE FETAL DEVELOPMENT, THE PREGNANT WOMAN UNDERWENT B-ULTRASOUND EXAMINATION, AND THE B-ULTRASOUND RESULTS SHOWED THAT THE FETUS WAS DEVELOPING WELL. ADMINISTRATION OF THIS TREATMENT MEDICATION WAS CONSIDERED TO BE UNNECESSARY. THE PATIENT IS IN GOOD HEALTH AND THERE WAS NO HARM TO THE FETUS. THE B-ULTRASOUND RESULTS SHOWED THAT THE FETUS WAS DEVELOPING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644583 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 42508UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other ARC I2000SR INST, 03M74-02, ISR62924| ARC I2000SR INST, 03M74-02, ISR62924