BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3791892 · Received May 6, 2014

    Report

    Report Number
    2517506-2014-00042
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE BIASED HIGH HB1C RESULTS IS USER ERROR. THE ACCOUNT FAILED TO FOLLOW THE INSTRUCTIONS FOR USE REQUIREMENT TO PERFORM A DILUTION OF THE SAMPLE WHEN THEY OBTAIN AN ABOVE ASSAY RANGE FLAG. THE DIMENSION(R) HB1C IFU STATES: "SAMPLES WITH RESULTS IN EXCESS OF 16.0% (151 MMOL/MOL), 25 G/DL (15.5 MMOL/L) HEMOGLOBIN OR 2.6 G/DL (1.6 MMOL/L) HBA1C WILL BE REPORTED AS ABOVE ASSAY RANGE AND SHOULD BE REPEATED ON DILUTION. IF THE MESSAGE PERSISTS ON THE DILUTED SAMPLE, REPORT THE RESULT AS GREATER THAN 16.0 % (151 MMOL/MOL). MANUAL DILUTION: MIX ONE PART OF CLINICAL LABORATORY REAGENT WATER (CLRW) AND ONE PART OF WELL MIXED WHOLE BLOOD. REASSAY THE DILUTION MIXTURE TO OBTAIN RESULTS WITHIN THE ANALYTICAL MEASUREMENT RANGE." AT THIS ACCOUNT THEY USED THEIR OWN LABORATORY ASSAY RANGE LIMIT OF 14% BUT DID NOT ADHERE TO THE REQUIREMENT TO RUN THE SAMPLE ON DILUTION BEFORE REPORTING OUT AN ABOVE ASSAY RANGE NUMERICAL RESULT. THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER REPRESENTATIVE REINFORCED THE INSTRUCTIONS WITH THE CUSTOMER TO CONFIRM IF RESULTS ARE TRULY ABOVE THE ASSAY RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED HB1C RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS WHO QUESTIONED THE RESULTS. DURING INVESTIGATION, THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED ON THE ORIGINAL SAMPLES. CORRECTED RESULTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED HB1C RESULTS. 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
    272047 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA4350

    Patients

    Seq Age Sex Outcome Treatment
    1