BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2823429 · Received November 8, 2012

    Report

    Report Number
    2050012-2012-01825
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED A NEW REAGENT SYRINGE DRIVE DUE TO DRIVE MOTION ERRORS AND GRINDING OF THE SYRINGE DRIVE. THE FSE NOTED THE LOWER 2 SCREWS, HOLDING THE BRACKET FOR SYRINGE DRIVE, CAME LOOSE. ONE SCREW COMPLETELY FELL OUT AND THE OTHER WAS 3/4 OUT CAUSING IMPRECISE REAGENT DELIVERY. THE FSE VERIFIED SYSTEM PERFORMANCE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. ON (B)(6) 2012, THE CUSTOMER FURTHER STATED 110 PATIENT SAMPLES WERE REANALYZED AND APPROXIMATELY ONE DOZEN HAD ERRONEOUS RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND AMENDED REPORTS WERE ISSUED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REAGENT PROBE B LEAKED FLUID FROM THE BOTTOM OF THE PROBE INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER STATED THE FIELD SERVICE ENGINEER (FSE) HAD REPLACED THE REAGENT SYRINGE DRIVE THE DAY PRIOR TO THE EVENT. THE CUSTOMER PERFORMED SYSTEM REBOOT AND NOTED REAGENT PROBE A ALSO LEAKED. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO SWITCH THE INSTRUMENT TO STOP STATE TO STOP THE PROBE LEAKAGE. THE CUSTOMER INDICATED MULTIPLE PATIENT SAMPLES PRODUCED BL ABS LO SYSTEM ERRORS ON ALL ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) TESTING. ALL SAMPLES WERE REANALYZED, ON THE SAME ANALYZER, AND VALID ALT AND AST RESULTS WERE OBTAINED. THE PHYSICIAN REQUESTED A REANALYSIS OF A LIPID PROFILE FROM (B)(6) 2012 DUE TO QUESTIONABLE RESULTS, AND AMENDED RESULTS WERE ISSUED. THE CUSTOMER INDICATED A TOTAL OF 82 PATIENT SAMPLES WERE REANALYZED AND FIVE PATIENT RESULTS WERE AMENDED. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1