BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 2646695 · Received July 9, 2012

    Report

    Report Number
    1415939-2012-01493
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    TO EXAMINE THE CUSTOMER CONCERN, THE INVESTIGATION TEAM REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THE CUSTOMER FACILITY. THIS REVIEW OF THIS DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOTS 10724M500, OR 12090M500. ADDITIONALLY, ACCURACY TESTING WAS PERFORMED USING ARCHITECT CA 125 II, LOT 10724M500, AND 12090M500. THREE PANELS OF KNOWN CONCENTRATION WERE TESTED ON ONE ARCHITECT INSTRUMENT AND EACH PANEL REPLICATE WAS WITHIN THE RESPECTIVE ACCEPTANCE RANGES. ALSO, HBR TESTING WAS PERFORMED AT THE CUSTOMER FACILITY WHICH IS KNOWN TO RESULT IN AN ASSAY INTERFERENCE EFFECT. THE MOST COMMON REPORTED ASSAY INTERFERENCE EFFECT IS A FALSE POSITIVE RESULT BUT FALSE NEGATIVE EFFECTS HAVE ALSO BEEN REPORTED. THE ASSAY RESULT FROM THE PRETREATMENT IS NEVER TO BE USED AS A REPORTABLE RESULT. BASED ON THIS REVIEW, IT HAS BEEN DETERMINED THAT THIS PRODUCT IS PERFORMING AS EXPECTED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED INCONSISTENT ARCHITECT CA125 RESULTS ON A PATIENT WITH TWO DIFFERENT REAGENT LOTS. IT IS UNCLEAR WHAT IS THE EXPECTED VALUE FOR THE PATIENT. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: HISTORICAL PATIENT TESTING WAS ARCHITECT CA125 OF APPROXIMATELY 100 U/ML; LOT 12090M500 = 18.4 (S/N (B)(4)) AND 18.4 U/ML (S/N (B)(4)); LOT 10724M500 = 78.9 U/ML(S/N (B)(4)). REFERENCE LAB: LOT 12090M500 = 19.0 U/ML; LOT 10724M500 = 91.0 U/ML; LOT 10724M500 = 97.9 U/ML (DILUTION OF 2); LOT 10724M500 = 96.8 U/ML (DILUTION OF 8); LOT 10724M500 = 100.8 U/ML (DILUTION OF 16); LOT 10724M500 = 7.4 U/ML (ADDITION OF HBR AGENT TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II LTK ABBOTT LABORATORIES 10724M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT CA125: LIST 02K45-25| LOT 12090M500, (B)(4)| LOT 12090M500, (B)(4)| ARCHITECT: LIST 3M74-01, SERIAL (B)(4),| ARCHITECT: LIST 3M74-01, SERIAL (B)(4),| ARCHITECT CA125: LIST 02K45-25