BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3211122 · Received July 8, 2013

    Report

    Report Number
    1415939-2013-00290
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED AGAINST AN EX-US PRODUCT (02K91-25) THAT HAS A SIMILAR PRODUCT (02K91-27) DISTRIBUTED IN THE US. PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED RESULTS FOR TWO PATIENT SAMPLES. BOTH PATIENT SAMPLES WERE RETESTED AND THE VALUES WERE LOWER THAN THE INITIAL RESULT. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THIS ISSUE. INITIAL ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 21130M500. THE TESTING WAS INCONCLUSIVE AND COMPLETED TROUBLESHOOTING OF THE INSTRUMENT WAS PERFORMED WITH NO INSTRUMENT ISSUES IDENTIFIED. PATIENT MEAN DATA (COLLECTED FROM ABBOTT LINK) WAS REVIEWED. THIS DATA WAS USED TO CALCULATE THE AVERAGE PATIENT MEDIAN, WHICH WAS IN TURN USED TO DETERMINE THE CONCENTRATION DIFFERENCE OF THE REAGENT LOT EVALUATED. THE CONCENTRATION DIFFERENCE WAS COMPARED TO THE TOTAL ALLOWABLE BIAS AS DEFINED BY AN INTERNAL REQUIREMENT FOR THE ARCHITECT CA19-9XR ASSAY. THE EVALUATED LOT DID NOT EXCEED THE INTERNAL REQUIREMENT FOR THE ARCHITECT CA19-9XR ASSAY. THE EVALUATION DETERMINED THAT THE LOT IN QUESTION READS PATIENT RESULTS CONSISTENTLY. BASED ON THE EVALUATION RESULTS, THERE WAS NOT ENOUGH INFORMATION TO SUGGEST A MALFUNCTION SINCE THE ISSUE WAS LIMITED TO TWO PATIENT SAMPLES AND THE CUSTOMER REPEATED THE TESTING FOR BOTH SAMPLES AND OBTAINED LOWER RESULTS FOR BOTH.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A HIGHER THAN EXPECTED RESULT OF 140 (UNIT OF MEASURE WAS NOT PROVIDED) FOR THE ARCHITECT CA19-9XR ASSAY. A RESULT OF 7 WAS OBTAINED UPON RETESTING THE SAMPLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311282 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 21130M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2K 03M74-01 SN (B)(4)