BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2981134 · Received February 27, 2013

    Report

    Report Number
    2517506-2013-00071
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 5, 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
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED HB1C RESULTS IS USER ERROR. THE ACCOUNT FAILED TO INPUT THE CORRECT LOT SPECIFIC SCALERS FOR THE LOT OF HB1C REAGENT. THE ACCOUNT ALSO FAILED TO ENTER THE CORRECT VALUES FOR THE HEMOBLOGIN LEVEL (HB) FOR THE LOT SPECIFIC CALIBRATORS. THE FALSELY ELEVATED RESULTS WERE CAUSED BY USING INCORRECT SCALERS AND HEMOGLOBIN BOTTLE VALUES AND THE ISSUE WAS RESOLVED BY ENTERING CORRECT SCALERS AND BOTTLE VALUES AND VERIFYING WITH QC. THE HB1C METHOD USES AN ADDITIONAL PARAMETER CALLED SCALER VALUES. THESE VALUES ARE POLYNOMIAL EQUATION FACTORS THAT HAVE BEEN DETERMINED FOR HB1C IN ORDER TO PROVIDE THE BEST CORRELATION TO THE HBA1C REFERENCE METHODOLOGY. THIS FEATURE WAS COMMUNICATED TO CUSTOMERS WITH THE LAUNCH OF HB1C (DF105A) IN THE HB1C 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 HB1C 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 FALSELY ELEVATED HB1C RESULTS WAS OBTAINED ON QC AND PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIANS. THE RESULTS WERE EVENTUALLY QUESTIONED AND IT WAS DETERMINED THAT INCORRECT METHOD SCALERS AND CALIBRATOR BOTTLE VALUES 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 FALSELY ELEVATED HB1C RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84235 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA3281

    Patients

    Seq Age Sex Outcome Treatment
    1