BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2475285 · Received March 2, 2012

    Report

    Report Number
    1415939-2012-00055
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    December 14, 2011
    Report Date
    March 1, 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

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1628664-2011-00749 UNDER A DIFFERENT SUSPECT DEVICE. (B)(4). ADD'L DEVICE: ARCH I2000SR LN: 03M74-01 SN: (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CA19-9 XR ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. THIS EVALUATION INDICATES THAT THE ARCHITECT CA19-9XR ASSAY IS PERFORMING AS INTENDED WITH NO NEW ISSUES. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE FOLLOWING RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ARCHITECT CA 19-9XR ASSAY: INITIAL RESULT OF >1200 U/ML (NEAT; REAGENT LOT 02949M500) ON ARCHITECT I2000SR SN: (B)(4), RETESTED AT 905.76 U/ML (1:2; REAGENT LOT 01083M500) ON ARCHITECT I2000SR SN: (B)(4). THE FOLLOWING RESULTS WERE ALL GENERATED WITH REAGENT LOT 01083M500 ON ARCHITECT I2000SR SN: (B)(4): 677.79 U/ML (1:10); >1200 U/ML (NEAT); 702.84 U/ML ; 495.55 U/ML (1:5); 596.74 U/ML (1:10). THE FOLLOWING DAY THE SAMPLE WAS RETESTED AGAIN: >1200 U/ML (NEAT); AND, 603.93 U/ML (1:10). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 01083M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN: 03M74-01 SN: (B)(4)| ARCH I2000SR LN: 03M74-01 SN: (B)(4)