BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000 SYSTEM FOR HBA1C

    MDR report key: 1531393 · Received November 10, 2009

    Report

    Report Number
    1217157-2009-00021
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    PMA / PMN Number
    K951361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE CONTROLS USED IN TESTING WERE RECONSTITUTED IN (B)(6) 2009. THE CONTROLS WERE STILL BEING USED BEYOND THE 90 DAYS RECOMMENDED USE LIFE. THERE WAS NO TREATMENT TO PT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS PT (B)(6) RESULTS ON THE DCA 2000 SYSTEM ARE LOW. CUSTOMER FURTHER REPORTS THAT THE LOT #0791 CONTROLS USED IN TESTING, WHILE IN RANGE, WERE LOW.

    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+ 0791

    Patients

    Seq Age Sex Outcome Treatment
    1