BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 3183160 · Received June 21, 2013

    Report

    Report Number
    1226181-2013-00280
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    PDJ
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS WAS CONTACTED BY THE CUSTOMER WHO REQUESTED ASSISTANCE WITH CALIBRATING HEMOGLOBIN A1C (HB1C). THE CUSTOMER RECEIVED ARITHMETIC ERRORS ON THE RAW CALIBRATION DATA FOR LOT GA4112. THE CUSTOMER CALCULATED THE DATA AND ACCEPTED A BAD CALIBRATION, THEREFORE THE TSC DETERMINED THAT THE CAUSE OF THE DISCORDANT HB1C RESULTS WAS USER ERROR. THE FALSELY ELEVATED HB1C RESULTS WERE CAUSED BY TESTING SAMPLES WITH A BAD CALIBRATION. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER RE-CALIBRATED USING AN ALTERNATE FLEX LOT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) PATIENT RESULTS WERE OBTAINED ON THREE PATIENTS ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE ELEVATED RESULTS. AFTER OBTAINING AN ACCEPTABLE CALIBRATION WITH LOT GA4028, THE CUSTOMER RE-TESTED THE PATIENT SAMPLES AND THE CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH HEMOGLOBIN A1C (HB1C) PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284006 DIMENSION® XPAND PLUS WITH HM IMMUNOASSAY ANALYZER PDJ SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION® XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1