BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT HL7 INTERFACE

    MDR report key: 1512161 · Received October 7, 2009

    Report

    Report Number
    2245578-2009-00034
    Event Type
    Other
    Date Received
    October 7, 2009
    Report Date
    October 7, 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 (APOC) NOTIFIED THE FDA (B)(4) DISTRICT OFFICE, (B)(6) 2009 BY TELEPHONE OF THE REMEDIAL ACTION. ABBOTT POINT OF CARE HAS DETERMINED THAT IT IS POSSIBLE UNDER CERTAIN CIRCUMSTANCES THAT SOME TEST RECORDS COULD HAVE THEIR STATUS UPDATE MESSAGE MIS-MATCHED WITH ANOTHER RECORD, RESULTING IN THE INCORRECT PT NAME, ORDER NUMBER OR COMMENT BEING INCLUDED IN THE CDS TEST RECORD ONLY. THIS INCORRECT PROCESSING CAN RESULT IN THE STATUS MESSAGE INTENDED FOR A RECORD TO BE UPDATED TO THE INCORRECT RECORD. TEST INFO THAT CDS SENDS TO AN EXTERNAL SYSTEM (LIS/HIS) IS NOT AFFECTED BY THIS ISSUE. THE I-STAT USE MODEL IS AT THE BEDSIDE, POINT-OF-CARE. NO ERRONEOUS RESULTS ARE GENERATED ON THE I-STAT HANDHELD AS A RESULT OF THIS ISSUE. THE PT RESULT IS ACCESSIBLE IN THE I-STAT HANDHELD AND ALL OF THE ASSOCIATED INFO THERE IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT HL7 INTERFACE I-STAT HL7 JJE ABBOTT POINT OF CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1