BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1720042 · Received June 11, 2010

    Report

    Report Number
    1823260-2010-03530
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    June 3, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE CRACK IN THE VALVE BODY MIGHT HAVE BEEN CAUSED BY SYSWASH SOLUTION. IT IS RECOMMENDED TO CHANGE THE VALVE BODY EVERY 6 MONTHS AS PART OF PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 1

    THE USER NOTED THE VALVE BODY ON THE ELECSYS 2010 WATER RESERVOIR WAS CRACKED AND WAS LEAKING. NO PATIENT WERE INVOLVED AND NO OPERATORS WERE HARMED. THE USER REPLACED THE VALVE BODY ON THE WATER RESERVOIR AND CONFIRMED THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    ADVERSE EVENT: "NO PATIENT HARM" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM: "SYRINGE CLOGGED DURING USE" (DEVICE CLOGGED [SYRINGE]). A SURGEON REPORTED SYRINGES CLOGGED DURING USE. FIVE LOT NUMBERS WERE REPORTED. NO PATIENT HARM. THIS IS THE THIRD OF FIVE MEDICAL DEVICE REPORTS BEING FILED; THIS REPORT IS FOR LOT NUMBER 09F18A.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1