BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2070782 · Received April 27, 2011

    Report

    Report Number
    1415939-2011-00132
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    October 27, 2009
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. WITH A UNIQUE COMBINATION OF INSTRUMENT AND REAGENT CONDITIONS THERE IS A POTENTIAL FOR SAMPLE CARRYOVER WHICH CAN RESULT IN FALSELY ELEVATED B-HCG CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED BOTH POSITIVE AND GREY ZONE B-HCG RESULTS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL B-HCG ((B)(4)) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS CHANGED FROM 06C21, ARCH B-HCG, (B)(4). MFR # 3005094123-2011-00538 HAS BEEN SUBMITTED TO ADDRESS THIS ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR GENERATED A FALSELY ELEVATED BHCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL BHCG RESULT OF 20 AND A REPEAT RESULT OF <1.20. DATA WAS REVIEWED AND FOUND NOT TO AFFECT THE CLINICAL INTERPRETATION OR MEDICAL DECISION MAKING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 78911JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR LN 01L86-01 (B)(4)| ARCH I1000SR LN 1L86-01 (B)(4)