BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 5605499 · Received April 25, 2016

    Report

    Report Number
    1226181-2016-00246
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE CLEANED THE CAPSTAN AREA, ALIGNED THE TOP SEAL COMPONENTS AND VERIFIED THE CUVETTE FORMATION. IT IS UNKNOWN IF THE OPERATOR WAS WEARING THE PERSONAL PROTECTIVE EQUIPMENT (PPE). THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION (4/26/2016): THE INITIAL MDR STATED THAT WHILE EMPTYING THE WASTE CONTAINER, THE OPERATOR WAS EXPOSED TO THE WASTE CONTAINER COMPONENTS. INFORMATION WAS PROVIDED BY THE CUSTOMER THAT THE OPERATOR WAS NOT EXPOSED TO THE WASTE CONTAINER COMPONENTS. THIS INFORMATION HAS BEEN CORRECTED. ADDITIONAL INFORMATION (4/26/2016): THE OPERATOR WAS WEARING A PERSONAL PROTECTIVE EQUIPMENT. THIS INFORMATION HAS BEEN AMENDED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION EXL 200 INSTRUMENT CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE OPERATOR OBSERVED THAT THE TOP SEAL OF THE CUVETTES WERE NOT SEALING AND CAUSED THE CUVETTES TO LEAK THE REAGENT INTO THE WASTE CONTAINER. WHILE EMPTYING THE WASTE CONTAINER, THE OPERATOR WAS EXPOSED TO THE WASTE CONTAINER COMPONENTS. THE OPERATOR DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT DUE TO THE EXPOSURE TO WASTE CONTAINER COMPONENTS.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION EXL 200 INSTRUMENT CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE OPERATOR OBSERVED THAT THE TOP SEAL OF THE CUVETTES WERE NOT SEALING AND CAUSED THE CUVETTES TO LEAK THE REAGENT INTO THE WASTE CONTAINER. THE OPERATOR WAS NOT EXPOSED TO THE WASTE CONTAINER COMPONENTS AND WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT WHILE EMPTYING THE WASTE. THE OPERATOR DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261486 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1