BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 4222305 · Received November 3, 2014

    Report

    Report Number
    1226181-2014-00560
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT THE CUVETTES WERE NOT PROPERLY SEALED. THE CSE REPLACED THE HEAT TORCH, WHICH IS RESPONSIBLE FOR SEALING THE CUVETTE FILM. THE CAUSE OF THE IMPROPERLY SEALED CUVETTES IS DUE TO A HEAT TORCH MALFUNCTION. THE CAUSE OF CUVETTE LIQUID SPLASHING INTO THE OPERATOR'S EYE IS USER ERROR. THE OPERATOR WAS NOT WEARING EYE PROTECTION DURING INSTRUMENT OPERATION. THE SIEMENS DIMENSION RXL MAX WITH HM OPERATOR'S GUIDE WARNS THE OPERATOR TO WEAR PROTECTIVE CLOTHING, GLOVES, AND SAFETY GLASSES DURING ROUTINE OPERATION OF THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    WHILE PERFORMING ROUTINE OPERATION ON A DIMENSION RXL MAX WITH HM INSTRUMENT, CUVETTE LIQUID ACCIDENTALLY SPLASHED IN THE OPERATOR'S EYE. THE OPERATOR IMMEDIATELY WASHED HER EYE USING A LABORATORY EYEWASH. THERE WAS NO MEDICAL TREATMENT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OPERATOR BEING SPLASHED IN THE EYE WITH CUVETTE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702625 DIMENSION RXL MAX WITH HM CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1