BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1901313 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06792
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THE CRACK IN THE WATER CAP (VALVE BODY) MIGHT HAVE BEEN CAUSED BY SYSWASH. THE PART IS RECOMMENDED TO BE EXCHANGED EVERY SIX MONTHS DURING PREVENTATIVE MAINTENANCE. NO INJURY DUE TO THE FLUID WAS REPORTED BY THE CUSTOMER. THE CRACKED WATER CAP (VALVE BODY) WAS REPLACED.

    Description of Event or Problem · 1

    THE USER NOTICED A WATER LEAK COMING OUT FROM THE BOTTOM OF THE ELECSYS 2010 RACK ANALYZER AND WAS DRIPPING ONTO THE CART THE ANALYZER WAS SETTING ON. USER SAID THE LEAK CONTINUED WHEN THE WATER CONTAINER WAS REMOVED FROM THE ANALYZER. THE INSTRUMENT OPERATOR OR LAB PERSONNEL WAS NOT HARMED AND THERE WERE NO PATIENT SAMPLES INVOLVED IN THE EVENT. THE FIELD SERVICE REPRESENTATIVE FOUND THE CAUSE WAS FLUIDICS FAILURE OF THE VALVE BODY FOR THE WATER RESERVOIR. HE REPLACED THE VALVE BODY. PERFORMANCE TESTS WERE PERFORMED WITH NO FURTHER LEAKS NOTED AND RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1