BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 6527034 · Received April 27, 2017

    Report

    Report Number
    1415939-2017-00066
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Report Date
    April 27, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE (5) LOTS WERE IN USE AND IT IS UNKNOWN WHICH RESULTS WERE PRODUCED WITH WHICH LOT. THESE MANUFACTURER REPORT NUMBERS COVER ALL 5 LOTS: 1415939-2017-00062 1415939-2017-00063 1415939-2017-00064 1415939-2017-00065 1415939-2017-00066 FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT AND ACCURACY TESTING MET ALL SPECIFICATIONS. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED IMPRECISE CA19-9 DATA ON THE ARCHITECT I2000SR ANALYZER. NO PATIENT HISTORY OR PREVIOUS RESULTS WERE AVAILABLE. THE FOLLOWING DATA WAS PROVIDED (U/ML): SID 002881 INITIAL 28.75, REPEATS 40.57, 34.15; SID 017230 INITIAL 34.41, REPEATS 38.52, 27.16; SID 021053 INITIAL 25.22, REPEATS 15.99, 21.14; SID 022927 INITIAL 76.01, REPEATS 75.35, 99.31; SID 032594 INITIAL 105.65, REPEAT 165.38; SID 051837 INITIAL 12.29, REPEATS 23.60, 16.69; SID 053899 INITIAL 376.13, REPEAT 495.51; SID 128258 INITIAL 46.47, REPEATS 50.90, 38.72; SID 141418 INITIAL 222.65, REPEATS 180.38, 224.41; SID 153249 INITIAL 4.72, REPEAT 6.69, 19.97, 4.73; SID 170801 INITIAL 16.65, REPEAT 10.77; SID 175160 INITIAL 47.08, REPEATS 44.33, 59.50; SID 180456 INITIAL 35.39, REPEAT 59.59, 26.64; SID 202742 INITIAL 8.71, REPEAT 11.81; SID 220586 INITIAL LESS THAN 2.0, REPEAT 41.20, 2.00, 20.56; SID 248237 INITIAL 16.51, REPEAT 47.67, 12.59, 35.41; SID 248528 INITIAL 37.87, REPEATS 37.14, 43.16, 45.41, 31.51; SID 257260 INITIAL 29.91, REPEAT 42.00, 30.74; SID 286736 INITIAL 20.70, REPEAT 11.68; SID 296969 INITIAL 22.55, REPEATS 20.52, 33.51; SID 309043 INITIAL 79.39, REPEATS 80.41, 58.50; SID 789360 INITIAL 28.25, REPEAT 19.08; SID 808660 INITIAL 52.35, REPEATS 51.81, 76.11, 49.10, 44.82; SID 888066 INITIAL 23.71, REPEATS 28.31, 18.27; SID 923140 INITIAL 32.28, REPEATS 37.55, 27.05; SID 924423 INITIAL 41.59, REPEATS 38.51, 32.06, 2.0, 3.78, 86.16; SID 952929 INITIAL 33.06, REPEATS 38.32, 27.58; SID 963127 INITIAL 43.30, REPEATS 38.60, 35.99; SID 975866 INITIAL 39.43, REPEATS 35.42, 40.55; THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307269 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 46559M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-02 SN (B)(4)