BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT LABORATORIES ISTAT DEVICE

    MDR report key: 2052932 · Received April 7, 2011

    Report

    Report Number
    MW5020214
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ABBOTT LABORATORIES ISTAT
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    (B)(6) CLINIC HAS RECENTLY DISCOVERED A POTENTIAL SCENARIO WHERE LABORATORY RESULTS FROM AN ABBOTT LABORATORIES ISTAT DEVICE COULD MISFILE THE INFO INTO ANOTHER PATIENT'S ELECTRONIC MEDICAL RECORD. THE DESIGN OF THE ABBOTT POINT OF CARE SYSTEM, ISTAT DEVICE USED IN CONJUNCTION WITH THE ABBOTT QCM3 SYSTEM, IS CONFIGURED SO THAT AN ISTAT CAN AUTO-GENERATE A LAB ORDER WHICH THEN FLOWS INTO THE QCM3 SERVER. THIS THEN SERVES AS AN INTERFACE BETWEEN THE LAB DEVICE (ISTAT), AND A HOSPITAL LABORATORY INFO SYSTEM (LIS). THE LIS SYSTEM IS THEN INTERFACED TO AN ELECTRONIC MEDICAL RECORD (EMR). THIS DESIGN RELIES ON A POSITIVE PT IDENTIFICATION AT THE BEDSIDE TO INSURE THE LAB INFO PROCESSED BY THE ISTAT AUTOMATICALLY FLOWS INTO THE CORRECT PT'S EMR. THE POSITIVE PT ID IS CURRENTLY ACCOMPLISHED BY SCANNING A PT'S ID ARMBAND WHICH HAS A LINEAR BARCODE CODED TO A UNIQUE PT ID NUMBER. WHAT WE HAVE DEMONSTRATED IN A TEST ENVIRONMENT IS THAT IT IS POSSIBLE, IN CERTAIN INSTANCES, TO READ A DIFFERENT (ERRONEOUS) PT ID NUMBER WITH THE BARCODE SCANNER UTILIZED BY THE ISTAT IF THE ISTAT IS HELD IN EXCESS OF 4"-8" AWAY FROM THE BARCODE. IF THE ISTAT IS POSITIONED A DISTANCE OF LESS THAN 4" INCHES THE CORRECT PT ID NUMBER WAS READ BY THE ISTAT BARCODE READER. BASED ON THE DESCRIPTION OF THE SYSTEM DESIGN, IF AN INCORRECT PT ID IS SCANNED BY THE ISTAT, THE RESULTS FROM PT A, WOULD AUTOMATICALLY POPULATE THE EMR OF PT B - INCORRECT PT ID INPUT FROM ISTAT SCANNER. WE BELIEVE THIS PROBLEM IS DUE TO THE OUTDATED TECHNOLOGY USED IN THE ISTAT BARCODE READER WHICH IS ONLY ABLE TO READ LINEAR BARCODES. THIS POTENTIAL SOURCE OF ERROR COULD BE RESOLVED BY HAVING ABBOTT UPDATE THE ISTAT BARCODE READER WITH NEWER TECHNOLOGY THAT WOULD READ A 2D BARCODE. THE 2D BARCODE IS LESS PRONE TO ERRORS IN SCANNING THAN A LINEAR BARCODE AS IT HAS THE ABILITY TO CONTAIN MORE DATA POINTS TO INSURE ACCURACY. ADDITIONALLY, THE TECHNOLOGY EMPLOYED IN 2D SCANNERS IS MORE ACCURATE AS THEY ARE ACTUAL IMAGING SYSTEMS RATHER THAN EMPLOYING SCANNING LASER TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABORATORIES ISTAT DEVICE ISTAT JJE ABBOTT LABORATORIES ISTAT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other