BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3790688 · Received May 5, 2014

    Report

    Report Number
    1415939-2014-00100
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AGAINST AN EX-US PRODUCT 902K91-25) WHICH HAS A SIMILAR PRODUCT 902K91-27) DISTRIBUTED IN THE US. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. REVIEW OF TICKET TRENDING DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY RELATED TO THIS ISSUE. ACCURACY TESTING WAS PERFORMED FOR LOT 31111M500 AND IT FAILED FOR PANEL 1 OUT OF SPECIFICATION. RETEST ALSO FAILED DUE TO PANEL 1 OUT OF SPECIFICATION. INSTRUMENT TROUBLESHOOTING DID NOT IDENTIFY ANY ISSUES. THE DATA ANALYSIS DEMONSTRATED THAT THE MEDIAN PATIENT VALUES HAVE NOT SHIFTED OVER TIME AND THAT THE REAGENT LOT IN QUESTION READ PATIENT RESULTS CONSISTENTLY. A DEFICIENCY WAS NOT IDENTIFIED AS THE PATIENT MEAN DATA REVIEW SHOWED THAT THE LIKELY CAUSE LOT PERFORMED PER SPECIFICATION. NO MALFUNCTION WAS IDENTIFIED; THIS ISSUE WAS LIMITED TO A DISCREET PATIENT SAMPLE. THE PANEL 1 FAILURE ISSUE WILL BE FURTHER INVESTIGATED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A HIGHER THAN EXPECTED RESULT OF MORE THAN 1200 U PER ML FOR THE ARCHITECT CA19 9 ASSAY. THE RESULT WAS FLAGGED AS IT REQUIRED DILUTION PER THE ASSAY PACKAGE INSERT. A RESULT OF 1031.54 U PER ML WAS GENERATED WITH THE AUTODILUTION. THE CUSTOMER THEN PERFORMED A MANUAL DILUTION AND QUESTIONED THE DISCREPANCY BETWEEN THE RESULT GENERATED WITH THE AUTO-DILUTION (1031.54) AND THE RESULTS GENERATED WITH THE MANUAL DILUTION. THE RESULTS GENERATED BY THE MANUAL DILUTION WERE AS FOLLOWS: 918, 932, 880, 706, 640 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268742 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 31111M500

    Patients

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