BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3168857 · Received June 13, 2013

    Report

    Report Number
    1226181-2013-00262
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Removal / Correction Number
    1226181-07/16/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE INSTRUMENT COVER FALLING DOWN WAS DUE TO A FAULTY COVER HINGE. THE FSE ADJUSTED THE COVER HINGE TENSION AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2013-00262 WAS FILED ON JUNE 13, 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. THE INITIAL MDR LISTED THE 510(K) NUMBER AS K073604. THE CORRECT 510(K) NUMBER FOR DIMENSION EXL W/LM INSTRUMENTS IS K130276.

    Description of Event or Problem · 1

    THE OPERATOR OF AN DIMENSION EXL WITH LM ANALYZER WAS PEFORMING ROUTINE WORK WHEN THE COVER OF THE ANALYZER FELL DOWN AND CAME IN CONTACT WITH HER HEAD. THE CUSTOMER SOUGHT MEDICAL ATTENTION AND WAS EVALUATED AT THE EMERGENCY ROOM. THE PHYSICIAN ORDERED A CAT SCAN AND DETERMINED THAT THE OPERATOR ENCOUNTERED NO INJURIES DUE TO THE INSTRUMENT COVER CONTACTING HER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270211 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMN EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1