BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 3242381 · Received July 23, 2013

    Report

    Report Number
    1226181-2013-00320
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 5, 2013
    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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2013-00320 WAS FILED ON JULY 23, 2013. ADDITIONAL INFORMATION (07/03/2014): 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. CORRECTION: THE INITIAL MDR LISTED THE 510(K) NUMBER AS K944093. THE CORRECT 510(K) NUMBER FOR DIMENSION EXL 200 INSTRUMENTS IS K073604.

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ANALYZED THE INSTRUMENT AND ADJUSTED THE COUNTERBALANCE ON THE BACK OF THE LID. THE LID NOW HAS PROPER TENSION TO STAY OPEN. THE CAUSE OF THE REGENT LID FALLING DOWN IS DUE TO IMPROPER LID TENSION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION EXL 200 ANALYZER WAS UNDER A REAGENT LID PERFORMING ROUTINE WORK. THE LID SHIFTED DOWN WHILE HE WAS WORKING ON THE INSTRUMENT. WHEN COMING OUT FROM UNDER THE LID HE CUT HIMSELF ON THE SIDE OF HIS FACE JUST ABOVE THE EYE. THE OPERATOR SUSTAINED A CUT BUT NO STITCHING WAS NECESSARY. HE CLEANED THE CUT AND APPLIED A BAND AID. NO MEDICAL TREATMENT BEYOND FIRST AID WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343214 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1