BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1337188 · Received March 10, 2009

    Report

    Report Number
    2050012-2009-00031
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 10, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EACH REAGENT KIT COMES WITH THE ORIGINAL MANUFACTURER'S IFU. IN MARCH 2007, AN UPDATED IFU WAS SENT TO EACH CUSTOMER ALONG WITH THE LETTER GIVING THE NEW PARAMETER SETTINGS TO ALLEVIATE THIS FALSE LOW PATIENT SITUATION. INSTRUMENT WAS NOT INSTALLED UNTIL THE FOLLOWING MONTH. EACH KIT ORDERED HAS THE UPDATED IFU FROM MARCH 2007. CUSTOMER IS RESPONSIBLE FOR REVIEWING THE IFU AND CONFIRMING IF USER DEFINED REAGENTS (UDR) PARAMETERS ARE SET CORRECTLY. SINCE THERE IS THE POTENTIAL FOR TREATMENT TO BE AFFECTED BASED ON FALSE LOW HCYX RESULTS, A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. BECKMAN COULTER, INC. (BCI) IS NOT THE LEGAL MANUFACTURER OF THE REAGENTS. THESE REAGENTS ARE USER DEFINED REAGENTS, AND ARE DESIGNED AND MANUFACTURED BY ANOTHER MANUFACTURER. THESE REAGENTS ARE DISTRIBUTED TO CUSTOMERS BY BCI. THE ORIGINAL MANUFACTURER CONDUCTED A PRODUCT CORRECTIVE ACTION IN 2007 AND 2009; BCI HAS FORWARDED THE CORRECTIVE ACTION INFORMATION TO BCI CUSTOMERS. SINCE BCI HAS THE PRIMARY INTERFACE WITH THE CUSTOMERS, BCI IS REPORTING THIS ISSUE TO THE FDA.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) RECEIVED REPORTS OF POTENTIAL FALSE LOW HOMOCYSTEINE (HCYX) PATIENT RESULTS BEING REPORTED DUE TO INCORRECT SOFTWARE USER DEFINED REAGENTS (UDR) PARAMETER SETTING. INCORRECT UDR SUBSTRATE DEPLETION INITIAL RATE FLAG WAS SET FOR THIS INSTRUMENT. THE SYSTEM WOULD NOT RECOGNIZE A VERY HIGH HOMOCYSTEINE SAMPLE CAUSING THE POTENTIAL FOR A SUBSTRATE DEPLETION EVENT TO OCCUR AND INCORRECTLY GIVE A FALSE LOW RESULT. .IT IS UNKNOWN AT THIS TIME IF ANY FALSE LOW RESULTS WERE REPORTED TO PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1