BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2663833 · Received July 20, 2012

    Report

    Report Number
    1415939-2012-01677
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    June 12, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 08056M500; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE CUSTOMER HAD PERFORMED DILUTION LINEARITY TESTING, THE DILUTION LINEARITY TESTING WAS ACCEPTABLE AND A REDUCTION IN RESULT WAS SEEN WHEN THE SAMPLE WAS TREATED WITH NEURAMINIDASE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CA19-9XR REAGENT LIST NUMBER 02K91, LOT NUMBER 08056M500, WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING THE ARCHITECT CA19-9XR ASSAY. THE CUSTOMER INDICATED THAT A (B)(6) PATIENT WHO HAD UNDERGONE AN OPERATION FOR COLORECTAL CANCER ON (B)(6) 2012 WAS BEING MONITORED. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: INITIAL: (B)(6) 2012: 28 U/ ML; RETEST: (B)(6) 2012 625 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 08056M500

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR ARCHITECT I2000SR ANALYZER:| LN 03M74-01, SN (B)(4)| LN 03M74-01, SN (B)(4)| ARCHITECT I2000SR ANALYZER: