BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2871080 · Received December 12, 2012

    Report

    Report Number
    2517506-2012-00348
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 USER INCORRECTLY ENTERED A NUMBER FOR THE LOT SPECIFIC SCALER B PARAMETER WHICH THEY INPUT INTO THE INSTRUMENT SOFTWARE. THEY FAILED TO INPUT THE CORRECT SCALER B VALUE AS PRINTED ON THE LOT SPECIFIC LABEL. 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 QC AND PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLE RESULTS WERE RE-RERUN AFTER A SHIFT IN QC AND PATIENT RESULTS WAS NOTICED AND A CALIBRATION SCALER VALUE WAS CORRECTED. LOWER RESULTS WERE OBTAINED. 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
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GA3197

    Patients

    Seq Age Sex Outcome Treatment
    1