BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2959596 · Received February 13, 2013

    Report

    Report Number
    3005094123-2013-00004
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    January 23, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS USING ARCHITECT TOTAL B-HCG LOTS 18945JN00 AND 20904JN00. IT IS UNKNOWN WHICH OF THE TWO LOTS GENERATED THE FALSELY ELEVATED B-HCG RESULT. (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 7K78/6C21) ON AN I1000SR INSTRUMENT WHICH ALSO UTILIZES THE ARCHITECT RUBELLA IGG (LIST NUMBER 6C17) ASSAY. THE INVESTIGATION DETERMINED THAT FALSELY ELEVATED B-HCG RESULTS OCCURRED DUE TO CARRYOVER ON THE ARCHITECT I1000SR PLATFORM WHEN THE FOLLOWING THREE STEPS OCCUR: RUBELLA ANCILLARY DILUENT HAS BEEN ASPIRATED BY THE REAGENT PROBE, A HIGH CONCENTRATION B-HCG SAMPLE IS THEN ASPIRATED BY THE REAGENT PROBE, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN INITIAL ARCHITECT B-HCG RESULT OF 53 MIU/ML WAS GENERATED. THE SAMPLE WAS REPEATED AND A RESULT OF 3 MIU/ML WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63490 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 18945JN00

    Patients

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