BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3513191 · Received December 10, 2013

    Report

    Report Number
    1628664-2013-00355
    Event Type
    Death
    Date Received
    December 10, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 15, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ARCHITECT ANALYZER IS CONNECTED TO AMS/MIDDLEWARE (SOFTWARE) WHICH IS CONNECTED TO THE HOSPITAL LIS (LABORATORY INFORMATION SYSTEM). THE CUSTOMER ALSO REPORTED SLOW LOCAL NETWORK RESPONSE DURING THIS TIME, WHICH WAS RESOLVED WITHOUT INTERVENTION, THEREFORE, THE SLOWER RESPONSE TIME WAS NOT A SYSTEMIC ISSUE. THE INVESTIGATION WAS LIMITED BECAUSE THE MIDDLEWARE LOGS ARE NO LONGER AVAILABLE. THESE LOGS ARE DELETED AFTER 7 DAYS AND THE CUSTOMER REPORTED THIS EVENT 10 DAYS AFTER IT OCCURRED. A COMPLAINT SEARCH FOUND NO TICKETS DESCRIBING A DELAY IN REPORTING PATIENT RESULTS ASSOCIATED WITH HOST COMMUNICATION ERRORS. THE DETAILED DATA COMMUNICATIONS ARE OUTLINED BELOW: THE ROUTINE SAMPLE WAS RECEIVED IN THE LABORATORY AT 15:35 AND BOOKED IN AT 15:57. THE LOGS SHOWED ARCHITECT RECEIVED AND PROCESSED AN ORDER FOR BOTH CLINICAL CHEMISTRY (CC) AND IMMUNOASSAY (IA) TESTS ON SAMPLE ID BK971342K ON (B)(6) 2013 AT 16:42:04. NO DELAY IN PROCESSING OF THE SAMPLE WAS FOUND. ALL OF THE CC TESTS WERE COMPLETED AND AVAILABLE ON THE ARCHITECT BY 17:01:32. THE IA RESULT WAS COMPLETED AND AVAILABLE ON THE ARCHITECT AT 17:22:40. MULTIPLE HOST COMMUNICATION ERRORS WERE GENERATED ON (B)(6) 2013 BETWEEN 16:09:21 AND 16:56:10; HOWEVER,MULTIPLE SAMPLE ORDERS WERE RECEIVED BY THE ARCHITECT DURING THIS TIME, INDICATING NO SYSTEMIC OUTAGE. NO ERRORS WERE FOUND INDICATING THE HOST COMMUNICATIONS WERE DISABLED BY THE ARCHITECT. THE LOG SHOWED THAT THE CC TESTS FOR SAMPLE ID BK971342K WERE REORDERED ON (B)(6) 2013 AT 21:45:21. ALL TESTS WERE COMPLETED BY 22:01:10. THE ABNORMAL POTASSIUM RESULTS WERE NOT REPORTED BY THE LABORATORY PERSONNEL TO THE PHYSICIAN UNTIL 23:02. BASED ON CUSTOMER FEEDBACK AND INSTRUMENT LOG INFORMATION, THERE WAS NO EVIDENCE OF DEVICE FAILURE BY THE ARCHITECT.

    Description of Event or Problem · 1

    THE BLOOD SAMPLE OF A (B)(6) FEMALE PATIENT WAS SENT TO THE LAB FOR ROUTINE TESTING (I.E. NOT MARKED STAT OR URGENT) FOR VARIOUS CHEMISTRY TESTS ORDERED BY A GENERAL PRACTIONER. WITHIN 12 MINUTES OF INITIATION, ALL 17 TEST RESULTS ORDERED WERE GENERATED BY THE ARCHITECT. THE POTASSIUM RESULT WAS ELEVATED (7.6 MMOL/L, NORMAL RANGE 3.5-5.1 MMOL/L) SO THE INSTRUMENT REFLEXED A REPEAT TEST THAT WAS COMPLETED FOUR MINUTES LATER (RESULT 7.5 MMOL/L). THE COMMUNICATION OF RESULTS TO THE HOSPITAL LIS SYSTEM WAS DELAYED DUE TO AN UNKNOWN CAUSE. [NOTE: THE ARCHITECT ANALYZER IS CONNECTED TO AMS/MIDDLEWARE (SOFTWARE) WHICH IS CONNECTED TO THE HOSPITAL LIS (LABORATORY INFORMATION SYSTEM).] THE HOSPITAL RERAN THE SAMPLE 6 HOURS LATER AND AGAIN THE POTASSIUM RESULTS WERE ELEVATED (7.6 MMOL/L) AND A REFLEX TEST CONFIRMED THE RESULT (7.6 MMOL/L). THESE RESULTS WERE VALIDATED BY THE CUSTOMER AN HOUR LATER, AND RESULTS WERE PHONED TO THE DOCTOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL, BUT DIED ON (B)(6) 2013 OF UNKNOWN CAUSES (TIME OF DEATH UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643853 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death ICT MODULE POTASSIUM