BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2872397 · Received December 5, 2012

    Report

    Report Number
    1217157-2012-00072
    Event Type
    Other
    Date Received
    December 5, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPEAT TESTING WAS NOT DONE ON THE TUBE SAMPLE. CONTROLS RUN ON (B)(6) 2012 WERE WITHIN RANGE. REFERENCE TEST METHOD IS UNKNOWN. NO PATIENT HISTORY IS AVAILABLE. THE REFERENCE LAB IS RUNNING A SIEMENS DIMENSION XPAND SYSTEM. TESTING TECHNIQUES WERE REVIEWED. MANUFACTURER WILL REQUEST CUSTOMER DO PRECISION CHECK WITH ABNORMAL QC X3 USING SAME REAGENT LOT. IF PRECISION PASSES THEN PREANALYTICAL SOURCES OF ERROR SHOULD BE CONSIDERED SUCH AS TESTING DONE BY NON KEY USERS, REAGENT HANDLING (FINGERPRINTS ON CARTRIDGE OPTICAL WINDOW OR DELAY IN USING AN OPENED CARTRIDGE) SAMPLE HANDLING ISSUES, NOT WIPING EXCESS BLOOD OFF THE CAPILLARY DEVICE OR SQUEEZING THE PUNCTURE SITE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A DISCORDANT RESULT ON A HBA1C TEST RUN ON THE DCA SYSTEM. THE PATIENT IS A KNOWN DIABETIC. PRIOR TO TESTING THE PHYSICIAN HAD INCREASED THE PATIENT INSULIN AND AS A RESULT, QUESTIONED THE 8.9 RESULT. THE PATIENT WAS NOT TREATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA VANTAGE DCA VANTAGE LCP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1