BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 3942486 · Received July 17, 2014

    Report

    Report Number
    1226181-2014-00385
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    January 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Removal / Correction Number
    1226181-07/16/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ADJUSTED THE HINGE TENSION AND DEMONSTRATED PROPER OPERATION TO THE CUSTOMER. THE CAUSE OF THE REAGENT LID FALLING ONTO THE OPERATOR WAS A MALFUNCTION OF THE REAGENT LID HINGES. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE INSTANCES OF DIMENSION EXL INSTRUMENT REAGENT LIDS FALLING DURING MAINTENANCE PROCEDURES. IT HAS BEEN DETERMINED THAT THE HINGE MAY LOSE ITS EFFECTIVENESS AND SLOWLY SHIFT DOWNWARD DURING MAINTENANCE PROCEDURES. CUSTOMERS IN THE UNITED STATES WERE SENT URGENT MEDICAL DEVICE CORRECTION (UMDC) 14-46 ENTITLED "DIMENSION EXL REAGENT LID HINGE ISSUE" AND CUSTOMERS OUTSIDE OF THE UNITED STATES WERE SENT URGENT FIELD SAFETY NOTICE (UFSN) 14-46 ENTITLED "DIMENSION EXL REAGENT LID HINGE ISSUE". THE UMDC/UFSN INFORM CUSTOMERS THAT THEIR CSE WILL INSPECT AND ADJUST THE TENSION ON THE REAGENT LID HINGES DURING EVERY VISIT. IF THE HINGES CAN NO LONGER BE PROPERLY ADJUSTED, THE HINGES WILL BE REPLACED. THE UMDC/UFSN ALSO INSTRUCTS CUSTOMERS TO CONTACT THE SIEMENS CUSTOMER CARE CENTER OR THEIR LOCAL SIEMENS TECHNICAL SUPPORT REPRESENTATIVE IF THEY OBSERVE THAT THE REAGENT LID IS SHIFTING DOWNWARD WHILE IN THE OPEN POSITION.

    Description of Event or Problem · 1

    THE REAGENT LID OF A DIMENSION EXL 200 INSTRUMENT FELL ONTO AN OPERATOR, COMING INTO CONTACT WITH THEIR HEAD. THE OPERATOR SUSTAINED A LACERATION TO HER HEAD DURING THE INCIDENT. THE OPERATOR DID NOT REQUIRE MEDICAL TREATMENT BEYOND FIRST AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418270 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1