BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 4103134 · Received September 19, 2014

    Report

    Report Number
    1415939-2014-00208
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. HIGH TEST RESULTS PATIENT; NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT CA19-9 LIST 02K91-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27. THE COMPLETE SID IS: SID (B)(4). AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT CA19-9XR REAGENTS LIST 02K91-25 LOT 33394M500 MANUFACTURED IN (B)(4) USA TO THE ARCHITECT I1000SR ANALYZER LIST 01L86-01 SN(B)(4) MANUFACTURED IN (B)(4) USA. MDR 1628664-2014-00210 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9XR RESULT FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6). (NOTE: PREVIOUS VALUE: 2 U/ML), INITIAL: 55.7 U/ML, REPEAT 3.8 U/ML, 5.4 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581866 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 33394M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST 01L86-01 (B)(4)| ARCHITECT I1000SR ANALYZER