BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 2080266 · Received April 6, 2011

    Report

    Report Number
    2245578-2011-00044
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 16, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN ABBOTT POINT OF CARE DISTRIBUTOR ((B)(4)) BECAME AWARE OF A CUSTOMER WHO STATED THAT THEY WERE YIELDING A HIGH RATE OF CODE 20, FILLING ISSUES AND STAR-OUTS. THERE WAS NO INFO AT THE TIME OF THE YIELD RATES. ON (B)(6) 2011, ABBOTT POINT OF CARE BECAME AWARE OF THE YIELD ISSUE BY THE ABBOTT POINT OF CARE DISTRIBUTOR. THERE WERE NO YIELD RATES AVAILABLE AT THIS TIME. ON (B)(6) 2011, ABBOTT POINT OF CARE BECAME AWARE THAT THE YIELD RATE FOR CODE 20 WAS 72 OUT OF 200 CARTRIDGES. THERE WERE NO YIELD RATES AVAILABLE FOR STAR OUTS OR FILL ISSUES. THE INVESTIGATION IS PENDING. BASED ON THE INFO AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE GKZ ABBOTT POINT OF CARE P10217

    Patients

    Seq Age Sex Outcome Treatment
    1