BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT DOWNLOADER RECHARGER, NETWORK

    MDR report key: 2000392 · Received February 9, 2011

    Report

    Report Number
    2245578-2011-00023
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 7, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING NETWORK DOWNLOADER RECHARGER SN (B)(4) (CAT 06F23-46). THE CUSTOMER STATED THERE WAS BLOOD ON THE SIDE OF THE DOWNLOADER. BASED ON THE INFO GIVEN, THERE WAS NO INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT DOWNLOADER RECHARGER, NETWORK DOWNLOADER RECHARGER, NETWORK JQP ABBOTT POINT OF CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1