BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2802781 · Received October 24, 2012

    Report

    Report Number
    2517506-2012-00289
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 24, 2012
    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
    IA, 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)(6) REAGENT. THE FALSELY ELEVATED RESULTS WERE CAUSED BY USING INCORRECT SCALERS AND THE ISSUE WAS RESOLVED BY ENTERING CORRECT SCALERS AND VERIFYING WITH QC. THE (B)(6) METHOD USES AN ADDITIONAL PARAMETER CALLED SCALER VALUES. THESE VALUES ARE POLYNOMIAL EQUATION FACTORS THAT HAVE BEEN DETERMINED FOR (B)(6) IN ORDER TO PROVIDE THE BEST CORRELATION TO THE (B)(6) REFERENCE METHODOLOGY. THIS FEATURE WAS COMMUNICATED TO CUSTOMERS WITH THE LAUNCH OF (B)(6) ((B)(4)) IN THE (B)(6) KIT SUPPLEMENT. SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE CORRECTION IN AUGUST 2012 TO REINFORCE INSTRUCTIONS TO CUSTOMERS TO ENTER AND VERIFY SCALERS WITH EVERY CALIBRATION OF NEW (B)(6) 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

    A GROUP OF (B)(6) RESULTS WAS OBTAINED ON QC AND PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE RESULTS WERE EVENTUALLY QUESTIONED AND IT WAS DETERMINED THAT INCORRECT METHOD SCALERS HAD BEEN IN USE FOR A PERIOD IN WHICH AT LEAST 6 PATIENT RESULTS HAD BEEN REPORTED. 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
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA3134

    Patients

    Seq Age Sex Outcome Treatment
    1