BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU600 CLINICAL CHEMISTRY ANALYZER WITH ISE

    MDR report key: 3623572 · Received February 11, 2014

    Report

    Report Number
    9612296-2014-00029
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN FSE WAS DISPATCHED TO THIS ACCOUNT. THE FSE REPLACED THE REAGENT PROBE, DI WATER FILTERS AND DEGASSER. THE FSE CLEANED THE WASH SYSTEMS AND MIXBARS. THE FSE THEN RAN A CALIBRATION AND QC CONTROLS WITHOUT INCIDENT. THIS FAILURE MODE OF THIS EVENT WAS A REAGENT NON-DISPENSE. THE MANUFACTURER REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE GENERATION OF AN ERRONEOUSLY LOW CALCIUM RESULT ON THEIR AU640. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LAB AND THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER OBTAINED A RESULT FOR CALCIUM OF 0.0 MG/DL ("G" FLAGGED). A G FLAG INDICATED THE RESULT IS BELOW THE LINEAR RANGE OF THE ASSAY. THE DATA PROVIDED BY THE CUSTOMER REVEALED THAT THE (B)(6) CALCIUM RESULT OCCURRED DUE TO A REAGENT NON-DISPENSE. A TYPICAL ABSORBANCE AT MEASURING POINT 0 FOR CALCIUM IS APPROXIMATELY 0.22 OD. THIS ERRONEOUS RESULT GENERATED AN OD OF 0.002 AND NO REACTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88969 AU600 CLINICAL CHEMISTRY ANALYZER WITH ISE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU643-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1