BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2875380 · Received December 17, 2012

    Report

    Report Number
    1628664-2012-00509
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    NIG
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.(B)(4).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED ON (B)(6) 2013, FROM ARCHITECT I2000SR ANALYZER (LIST 03M74-02, SN ISR07140) MANUFACTURED AT ABBOTT MANUFACTURING, (B)(4) TO ARCHITECT CA19-9XR (LIST 02K91-35, LOT 18070M500) MANUFACTURED AT ABBOTT LABORATORIES, (B)(4). HOWEVER, A PRODUCT EVALUATION OF THE ARCHITECT CA19-9XR REAGENT LIST 02K91-35 WAS PERFORMED AND ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ANALYTE. THE PRODUCT EVALUATION IDENTIFIED NO PRODUCT DEFICIENCY AND NO MALFUNCTION FOR THE ARCHITECT CA19-9XR ASSAY (LIST 02K91-35, LOT 18070M500), AND SINCE THERE WAS NO DEATH OR INJURY, THIS EVENT IS NOT-REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED RESULT ON THE CA19-9 ASSAY FOR ONE PATIENT WHILE USING THE ARCHITECT I2000SR INSTRUMENT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER PROVIDED THE FOLLOWING DATA: 51.87 U/ML, RETEST 6.99 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER NIG ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT CA19-9| LIST 2K91-35 LOT 18070M500| ARCH CA19-9 LIST 2K91-35 LOT 18070M500