BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2070686 · Received April 27, 2011

    Report

    Report Number
    1628664-2011-00190
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    January 24, 2011
    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 ARCH I1000SR, (B)(4) TO ARCH(B)(4), MANUFACTURING SITE (B)(4). MFR # 3005094123-2011-00564 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-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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED FALSELY ELEVATED B-HCG RESULTS FOR ONE 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 AUTOMATED IMMUNOASSAY ANALYZER DHA A.I.D.D LONGFORD 89908JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR: LN 01L86-01 SN (B)(4)| ARCH BHCG: LN 7K78-25 LOT 89908JN00