BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3120928 · Received May 20, 2013

    Report

    Report Number
    2517506-2013-00206
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Removal / Correction Number
    2517506-08-29-2012-013-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE (B)(6) RESULTS IS USER ERROR. THE ACCOUNT FAILED TO INPUT THE CORRECT LOT SPECIFIC SCALERS FOR THE LOT OF (B)(4) REAGENT. THE (B)(6) RESULTS WERE CAUSED BY USING INCORRECT SCALERS AND THE ISSUE WAS RESOLVED BY ENTERING CORRECT SCALERS AND VERIFYING WITH QC. THE (B)(4) METHOD USES AN ADDITIONAL PARAMETER CALLED SCALER VALUES. THESE VALUES ARE POLYNOMIAL EQUATION FACTORS THAT HAVE BEEN DETERMINED FOR (B)(4) IN ORDER TO PROVIDE THE BEST CORRELATION TO THE (B)(4) REFERENCE METHODOLOGY. THIS FEATURE WAS COMMUNICATED TO CUSTOMERS WITH THE LAUNCH OF (B)(4) (DF105A) IN THE (B)(4) KIT SUPPLEMENT. SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE CORRECTION, COMMUNICATION 12-38, IN AUGUST 2012 TO REINFORCE INSTRUCTIONS TO CUSTOMERS TO ENTER AND VERIFY SCALERS WITH EVERY CALIBRATION OF NEW (B)(4) FLEX(R) REAGENT CARTRIDGE LOTS AND WITH EACH RECALIBRATION OF THE SAME FLEX(R) LOT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) RESULTS WERE OBTAINED ON SURVEY SAMPLES AND PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS. THE RESULTS WERE EVENTUALLY QUESTIONED AND IT WAS DETERMINED THAT INCORRECT METHOD SCALERS HAD BEEN IN USE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221838 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA3351

    Patients

    Seq Age Sex Outcome Treatment
    1