BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM ARSENAZO REAGENT

    MDR report key: 2120784 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02250
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CJY
    PMA / PMN Number
    K061575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS RESULTS OBTAINED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH CALCIUM (ARSENAZO) RESULTS FOR 10 PATIENT SAMPLES ASSAYED WITH THE CALCIUM (ARSENAZO) REAGENT ON AN AU5421 CHEMISTRY SYSTEM RANDOM ACCESS CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ORDERING PHYSICIAN QUESTIONED THE UNEXPECTEDLY HIGH CALCIUM RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER OBSERVED A COLORED STAIN ON THE REMAINING REAGENT BOTTLES AND BOX THEY WERE PACKAGED IN. THE CUSTOMER BELIEVES IT IS POSSIBLE THAT THE CALCIUM REAGENT BOTTLE USED FOR THE ANALYSES MAY HAVE BEEN CONTAMINATED. FURTHER INVESTIGATION REVEALED THAT THE CALCIUM ASSAY ON THE ANALYZER WAS IN NEED OF RECALIBRATION. BCI ADVISED THE CUSTOMER TO RECALIBRATE THE ASSAY WITH A FRESH BOTTLE OF CALCIUM REAGENT. THE CUSTOMER RE-ASSAYED THE 10 PATIENT SAMPLES ON AN AU2700 CHEMISTRY ANALYZER AND OBTAINED EXPECTED LOWER CALCIUM RESULTS. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THE EVENT. HOWEVER, AN INVALID CALCIUM CALIBRATION CONTRIBUTED TO THE GENERATION OF THE ERRONEOUSLY HIGH CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCIUM ARSENAZO REAGENT CALCIUM TEST SYSTEM CJY BECKMAN COULTER, INC. 9891

    Patients

    Seq Age Sex Outcome Treatment
    1 AU5421 CHEMISTRY SYSTEM