BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000+

    MDR report key: 2974255 · Received February 15, 2013

    Report

    Report Number
    1217157-2013-00019
    Event Type
    Other
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K963142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THEY HAVE NOT RUN CONTROLS OR AN OPTICAL TEST ON THE SYS. THE CAUSE FOR THE DISCORDANT HBA1C RESULTS IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCORDANT HBA1C RESULTS WHEN RUN ON DIFFERENT INSTRUMENTS. THERE WAS NO INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69675 DCA 2000+ DCA 2000+ LCP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1