BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1801216 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04825
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE CRACK IN THE VALVE BODY MIGHT HAVE BEEN CAUSED BY SYSWASH SOLUTION. THE PART HAS BEEN RECOMMENDED TO BE EXCHANGED EVERY 6 MONTHS ON PREVENTATIVE MAINTENANCE. NO PATIENTS OR SAMPLES WERE AFFECTED AND NO INJURY DUE TO THE FLUID WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    THE USER DISCOVERED THE VALVE BODY ON THE WATER RESERVOIR WAS CRACKED AND LEAKING WHEN SHE REMOVED THE RESERVOIR TO BE REFILLED. THE USER REPLACED THE CRACKED VALVE BODY WITH A VALVE BODY FROM A REPLACEMENT WATER RESERVOIR. NO PATIENTS WERE AFFECTED AND NO INSTRUMENT OPERATORS OR LAB PERSONNEL WERE INJURED.

    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