BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000 SYSTEM FOR HBA1C

    MDR report key: 1519049 · Received October 27, 2009

    Report

    Report Number
    1217157-2009-00020
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 1, 2009
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    PMA / PMN Number
    K911625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED SPORADICALLY HIGH RESULTS WHEN MONITORING PTS FOR HBA1C LEVELS USING THE DCA 2000 SYSTEM. INITIAL TEST: 10.1%, RETEST: 6.1%. UNUSED CARTRIDGES WERE RETURNED FOR TESTING.

    Description of Event or Problem · 2

    CUSTOMER EXPERIENCED SPORADICALLY HIGH RESULTS WHEN MONITORING PTS FOR HBA1C LEVELS USING THE DCA 2000 SYSTEM. INITIAL TEST: >14%, RETEST: 7.1%. UNUSED CARTRIDGES WERE RETURNED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA 2000 SYSTEM FOR HBA1C DCA 2000 SYSTEM FOR HBA1C LCP BAYER CORP. 2000/2000+

    Patients

    Seq Age Sex Outcome Treatment
    1
    2