BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA SYSTEMS HBA1C REAGENT

    MDR report key: 1695393 · Received May 18, 2010

    Report

    Report Number
    1217157-2010-00008
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ADVISED TO DO EQUIPMENT MAINTENANCE AND TO RETEST SAMPLE USING ANOTHER BOX OF REAGENTS. THE CUSTOMER HAS NOT SEEN ANY SIMILAR DISCORDANT RESULTS WITH THE LOT THEY ORIGINALLY OBSERVED THE PROBLEM OR WITH THE REPLACEMENT LOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS OBTAINING A DCA HBA1C RESULT THAT WAS HIGHER THAN THE REFERENCE LAB RESULT. CONTROLS WERE IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA SYSTEMS HBA1C REAGENT DCA SYSTEMS HBA1C REAGENT LOM BAYER HEALTHCARE LLC 5035C 0842080

    Patients

    Seq Age Sex Outcome Treatment
    1