BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT 1 ANALYZER

    MDR report key: 1478392 · Received September 10, 2009

    Report

    Report Number
    2245578-2009-00032
    Event Type
    Other
    Date Received
    September 10, 2009
    Date of Event
    August 17, 2009
    Report Date
    September 10, 2009
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO REMOVE PRODUCT FROM THE FIELD. ABBOTT POINT OF CARE NOTIFIED THE FDA (B)(4) DISTRICT OFFICE, ON 08/21/2009 BY TELEPHONE AND ON 08/25/2009 IN WRITING, OF THE REMEDIAL ACTION. ABBOTT POINT OF CARE HAD BECOME AWARE THAT THE STORAGE TEMPERATURE ON THE OUTSIDE SHIPPING BOX OF THE I-STAT 1 ANALYZER WAS INCORRECT FOR ANALYZERS SHIPPED BETWEEN DECEMBER 2008 AND JULY 2009. THE LABEL INDICATED STORAGE CONDITIONS OF -20 TO 50 DEGREES CELSIUS AND THE CORRECT CONDITIONS ARE -10 TO 46 DEGREES CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 1 ANALYZER I-STAT ANALYZER JJE ABBOTT POINT OF CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1