BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2070744 · Received April 27, 2011

    Report

    Report Number
    1415939-2011-00128
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    February 19, 2009
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, (B)(4), ARCHITECT TOTAL B-HCG, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, (B)(4), ARCHITECT TOTAL B-HCG. 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 (LIST NUMBER (B)(4)) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER (B)(4)) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE MANUFACTURING SITE HAS MOVED FROM (B)(4). MFR # 3005094123-2011-00561 HAS BEEN SUBMITTED TO ADDRESS THIS ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSE POSITIVE BHCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL BHCG RESULT OF 30 IU/L ON (B)(6) 2009. A NEW SAMPLE FROM THE SAME PATIENT GENERATED A BHCG RESULT OF <1.2 IU/L ON (B)(6) 2009. THE FALSE POSITIVE RESULT WAS ATTRIBUTED TO USER ERROR (BHCG REAGENT NOT INSPECTED AND FIBRIN IN THE INITIAL PATIENT SAMPLE. 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 68916JN00

    Patients

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