BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3500455 · Received December 4, 2013

    Report

    Report Number
    2050012-2013-00793
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER, (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE REAGENT PROBES WERE LEAKING. THE FSE DETERMINED THE FAILURE MODE WAS THE HAMILTON 4-WAY VALVE (P/N 970835) WHICH WAS REPLACED. AFTER REPLACING THE VALVE, THE FSE VERIFIED REPAIRS AND NO FURTHER LEAKING WAS OBSERVED. IDENTIFICATION OF FAILURE MODE: THE FAILURE MODE IS THE HAMILTON HV 4-4 VALVE. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED. LEAKING REAGENT PROBES CAN IMPACT ANY OR ALL CHEMISTRIES, INCLUDING CRITICAL CHEMISTRIES. THE BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BOTH REAGENT PROBES WERE LEAKING WHEN USING THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER CHECKED FOR LOOSE SYRINGE FITTINGS, THE FITTINGS WERE FOUND TO BE TIGHT AND NOT LOOSE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT, LAB COAT AND GLOVES. THERE WAS NO REPORTED EXPOSURE OR INJURY. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629560 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1