BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QS/1 DATA SYSTEMS

    MDR report key: 873052 · Received June 25, 2007

    Report

    Report Number
    MW5002829
    Event Type
    Injury
    Date Received
    June 25, 2007
    Date of Event
    April 27, 2007
    Report Date
    June 25, 2007
    Manufacturer
    QS/1 DATA SYSTEMS
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE HAVE NOTICED THAT QS/1 HAS NOT BEEN FLAGGING COMMON INTERACTIONS. WE NOTICED ONE SPECIFIC INSTANCE WHERE A PT WAS CONTINUOUSLY GIVEN HYDROCHLOROTHIAZIDE AND FUROSEMIDE, BECAUSE THE QS/1 SYSTEM DID NOT ALERT TECHNICIANS OR PHARMACISTS THAT THE PT WAS TAKING BOTH. WE DEPEND ON OUR COMPUTER OPERATING SYSTEM TO ALERT US OF DRUG INTERACTIONS. WE ALSO NOTICED AN INSTANCE WHERE ONLY 4 REFILLS OF A CONTROLLED SUBSTANCE WERE AUTHORIZED IN QS/1 AND IT ALLOWED OUR STAFF TO DISPENSE 5 REFILLS. IT DOES NOT APPEAR THAT ANYTHING WAS ENTERED INTO THE QS/1 SYSTEM INCORRECTLY. THIS IS VERY CONCERNING, DUE TO THE LEGAL ISSUES OF DISPENSING CONTROLLED SUBSTANCES THAT WERE NOT AUTHORIZED BY THE PHYSICIAN. WE DEPEND ON OUR COMPUTER OPERATING SYSTEM TO COUNT THE NUMBER OF REFILLS AUTHORIZED CORRECTLY. WE ALSO NOTICED AN INSTANCE WHERE QS/1 TRANSFERRED 11 REFILLS FROM REMOTE 1 WHEN IT SHOULD HAVE TRANSFERRED 4 REFILLS -THE AMOUNT REMAINING ON THE RX-. OUR SYSTEM IS STILL LOCKING UP WHEN WE HIT SAVE AFTER A TRANSFER. OUR SYSTEM IS STILL GIVING US AN ERROR STATING THAT RX HAS ALREADY BEEN FILLED TODAY WHEN AN RX IS TRANSFERRED INTO OUR STORE -NOT FILLED- AND THEN LATER ENTERED IN AS A NEW PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QS/1 DATA SYSTEMS NRX PHARMACY MANAGEMENT SOFTWARE LNX QS/1 DATA SYSTEMS NRX

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening NRX PHARMACY MANAGEMENT SOFTWARE