BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3080066 · Received April 26, 2013

    Report

    Report Number
    2050012-2013-00294
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VERIFIED SYSTEM PERFORMANCE AND DID NOT OBSERVE ANY SYSTEM ISSUES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE REAGENT CARTRIDGE THAT WAS NEAR EMPTY HAD BEEN DISCARDED BY THE CUSTOMER. THE CUSTOMER INDICATED REPLACING THE NEAR EMPTY CREATININE CARTRIDGE RESOLVED THE ISSUE. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED ALL THREE LEVELS OF QUALITY CONTROL (QC) FOR CREATININE (CR-S) WERE OUT OF SPECIFICATION INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM USED IN CONJUNCTION WITH THE CREATININE REAGENT. THE CUSTOMER STATED THE CREATININE REAGENT CARTRIDGE WAS NEAR EMPTY AND REPLACED THE CARTRIDGE AND PERFORMED CONTROLS; ALL THREE QC LEVELS WERE WITHIN RANGE. THE CUSTOMER THEN ANALYZED ONE PATIENT'S SAMPLE AND OBTAINED A FALSELY LOW CREATININE (CR-S) RESULT OF <27 UMOL/L. THE CUSTOMER REANALYZED THE SAMPLE ON AN ALTERNATE SYSTEM AND RECOVERED A HIGHER RESULT OF 68 UMOL/L. THE CUSTOMER THEN REANALYZED THE SAMPLE ON THE ORIGINAL SYSTEM AND OBTAINED A VALUE OF <27 UMOL/L. THE CUSTOMER RETESTED THE SAMPLE AGAIN, ON THE ALTERNATE SYSTEM, AND OBTAINED A RESULT OF 63 UMOL/L WHICH WAS REPORTED TO THE HOSPITAL. THE CUSTOMER STATED THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182900 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR