BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2070675 · Received April 27, 2011

    Report

    Report Number
    1628664-2011-00185
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    August 6, 2010
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS CHANGED FROM THE (B)(4). MFR # 3005094123-2011-00548 HAS BEEN SUBMITTED TO ADDRESS THIS ERROR

    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)(6) CONCENTRATIONS ON THE ARCHITECT I1000SR SYSTEM. NEGATIVE SAMPLES HAVE RETURNED (B)(6) AND GREY ZONE (B)(6) RESULTS WHEN A HIGH CONCENTRATION (B)(6) SAMPLE IS ASSESSED PRIOR TO THE NEGATIVE SAMPLE WITH ARCHITECT TOTAL (B)(6) (LIST NUMBER 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT (B)(6) (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED FALSELY ELEVATED (B)(6) RESULTS FOR THREE PATIENT SAMPLES. 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 AUTOMATED IMMUNOASSAY ANALYZER DHA A.I.D.D LONGFORD 81919JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH BHCG REAGENT LN 7K78-25 LOT 81919JN00| ARCH I1000SR LN 01L86-01 (B)(4)