BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERNER HNA MILLENIUM

    MDR report key: 408446 · Received July 30, 2002

    Report

    Report Number
    MW1025720
    Event Type
    Injury
    Date Received
    July 30, 2002
    Date of Event
    July 23, 2002
    Report Date
    July 24, 2002
    Manufacturer
    CERNER CORP.
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR WAS ASKED TO ADJUST THIS PT'S ZOSYN DOSE FOR RENAL DYSFUNCTION. THE MOST RECENT SERUM CREATININE REPORTED BY LAB VIA THE CERNER SYSTEM WAS 1.5 MG/DL, YIELDING AN ESTIMATED CRCL ABOUT 35 ML/MIN, SO RPTR DOSES ZOSYN 2.25 GM IV Q6H. TODAY RPTR DISCOVERED THAT THE PT'S SCR ON 7/23 WAS ACTUALLY 3.5 MG/DL, YIELDING AN ESTIMATED CRL ABOUT 15 ML/MIN. THEREFORE THE PT'S ZOSYN DOSE SHOULD HAVE BEEN 2.25 GM IV Q12H. THE PT WAS AT RISK FOR MORBIDITY OF THIS ERROR HAD NOT BEEN CAUGHT. RPTR SPOKE WITH A GENTLEMAN FROM LAB, WHO COULD NOT VERIFY WHERE THE ENORMOUS VALUE HAD COME FROM. ALL LAB DATA IS TRACKED ELECTRONICALLY BY WHO ENTERED THE ORDER, WHO COLLECTED THE SPECIMEN, WHO VERIFIED THE RESULTS, ETC. THIS IS TRACKED BY THE USER ENTERING A USER NAME AND PASSWORD UPON ENTERING THE CERNER SYSTEM. THE SCR VALUE REPORTED AT 1.5 HAD NO TRACKING DATA ASSOCIATED WITH IT. IT SEEMS TO HAVE JUST APPEARED ON THIS PT'S LAB PROFILE, PERHAPS BECAUSE OF A GLITCH.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/19/03: THE HOSPITAL'S INFO TECHNOLOGY SERVICE GRANTED PHARMACY EMPLOYEES ACCESS TO THE LABORATORY'S SERUM CREATININE RESULTS TO ADD A UNIT (MG/DL) DISPLAY. THE ADDITION OF THIS UNIT OF MEASURE INITIALLY LED TO A DRUG DOSING INACCURACY. THE ADDITION OF THE UNITS WAS INTERPRETED AS A NEW SERUM CREATININE RESULT FROM THE LABORATORY ON THE EVENT DATE REPORTED, WHEN IN FACT, IT WAS RESULT FROM 14 DAYS EARLIER. THIS RESULTED IN TWO ADD'L DOSES OF ZOSYN BEING ADMINISTERED TO AN INPATIENT. THE CLIENT CONFIRMED THE DOSING ERROR ON SEPTEMBER 13, 2002. NO ADD'L PT CARE ISSUES WERE REPORTED TO CERNER. THE IMMEDIATE ACTION TAKEN TO RESOLVE THE ISSUE WAS TO REVOKE THE PHARMACY EMPLOYEES' ACCESS TO LABORATORY RESULTS. THE PHARMACY IS NOW GRANTED "READ ONLY" ACCESS. THE DATABASE IS BEING CORRECTED TO ALLOW ONLY ONE (1) MG/DL UNIT VALUE TO DISPLAY WITHIN EITHER THE PHARMACY INFO SYSTEM OR THE LABORATORY INFO SYSTEM. THEREFORE, THE PHARMACY WILL NO LONGER NEED TO ADD UNITS TO A LABORATORY RESULTS. CERNER HAS DISTRIBUTED A SERVICE FLASH NOTIFICATION TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SERVICE FLASH NOTIFICATIONS INCLUDE A DESCRIPTION OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERNER HNA MILLENIUM COMPUTER SYSTEM MMH CERNER CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention