BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2230974 · Received September 1, 2011

    Report

    Report Number
    3005094123-2011-00509
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    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

    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 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT FALSELY ELEVATED B-HCG RESULTS OCCURRED DUE TO CARRYOVER ON THE ARCHITECT I1000SR PLATFORM WHEN THE FOLLOWING THREE STEPS OCCUR: 1-RUBELLA ANCILLARY DILUENT HAS BEEN ASPIRATED BY THE REAGENT PROBE 2-A HIGH CONCENTRATION B-HCG SAMPLE IS THEN ASPIRATED BY THE REAGENT PROBE 3-REAGENT PROBE ASPIRATES A NEGATIVE SAMPLE OR B-HCG CONJUGATE FOLLOWED BY A B-HCG NEGATIVE SAMPLE. CARRYOVER ON THE ARCHITECT I1000SR ONLY OCCURS WHEN A HIGH CONCENTRATION B-HCG SAMPLE IS ASPIRATED AFTER THE ARCHITECT RUBELLA IGG (LN 6C17) ASSAY ANCILLARY DILUENT. THE CAUSATIVE AGENT OF THE FALSELY ELEVATED RESULTS FOR THE NEGATIVE B-HCG SAMPLES ON THE I10000SR IS THE POLY SODIUM 4-STYRENE-SULFONATE COMPONENT OF THE ARCHITECT RUBELLA IGG ASSAY SPECIFIC DILUENT. THIS COMPONENT CAUSES REAGENT MEDIATED SAMPLE CARRYOVER OF B-HCG INTO B-HCG NEGATIVE SAMPLES. CARRYOVER WAS ONLY OBSERVED ON THE ARCHITECT I1000 PLATFORM SERIES. REFORMULATION OF THE ARCHITECT RUBELLA IGG/ARCHITECT B-HCG ASSAYS WILL BE EVALUATED TO MITIGATE AGAINST THIS COMPONENT BINDING AND CARRYING HIGH B-HCG SAMPLES INTO LOW OR NEGATIVE B-HCG SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSE POSITIVE BHCG RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT I1000SR ANALYZER GENERATED AN INITIAL BHCG RESULT OF 57 MIU/ML AND A REPEAT BHCG RESULT OF ZERO. 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 DHA A.I.D.D LONGFORD 02928JN00

    Patients

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