BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP CA15-3 ASSAY

    MDR report key: 5234159 · Received November 18, 2015

    Report

    Report Number
    1219913-2015-00179
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    April 16, 2015
    Report Date
    November 17, 2015
    Manufacturer
    SIEMENS HEATHCARE DIAGNOSTICS, INC.
    Product Code
    MOI
    PMA / PMN Number
    K012357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED INITIAL MDR 121993-2015-00179 ON NOVEMBER 18, 2015. ON 11/19/2015 - CORRECTION: SECTION OF THE INITIAL MDR HAD THE INCORRECT DATE. THE CORRECT DATE IS (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    SIEMENS PERFORMED AN INTERNAL INVESTIGATION. SIEMENS DETERMINED THAT SOME ADVIA CENTAUR SYSTEMS (B)(4) REAGENT READYPACKS FROM LOT 043156 FAIL TO CALIBRATE DUE TO HIGH SLOPE CAUSED BY LOW RELATIVE LIGHT UNITS (RLU) OUTPUT WHILE MOST REAGENT READYPACKS LOT 043156 RESULT IN ACCEPTABLE CALIBRATION. CUSTOMERS ARE NOT ABLE TO PERFORM QUALITY CONTROL (QC) OR REPORT RESULTS DUE TO THE CALIBRATION FAILURES WHEN AN AFFECTED READYPACK IS USED. ROOT CAUSE WAS NOT DETERMINED PRIOR TO LOT EXPIRATION, AND THE ISSUE DOES NOT APPEAR TO BE A SYSTEMIC (B)(4) PROBLEM. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED CALIBRATION FAILURES DUE TO HIGH SLOPE RESULTS EXCEEDING DEFINED RANGES ON TWO FRESHLY OPENED REAGENT READYPACKS OF ADVIA CENTAUR CP (B)(4) LOT 043156. ACCEPTABLE CALIBRATION WAS OBTAINED WITH WHEN CUSTOMER USED ANOTHER REAGENT READYPACK OF THE SAME LOT. THE TWO READYPACKS WITH FAILING CALIBRATIONS WERE NOT USED FOR SAMPLE MEASUREMENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED CALIBRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763323 ADVIA CENTAUR CP CA15-3 ASSAY CHEMILUMINESCENCE IMMUNO ASSAY KIT FOR THE DETERMINATION OF CA 15-3 ANTIGEN MOI SIEMENS HEATHCARE DIAGNOSTICS, INC. N/A 043156

    Patients

    Seq Age Sex Outcome Treatment
    1