BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1347027 · Received March 23, 2009

    Report

    Report Number
    1628664-2009-00118
    Event Type
    Malfunction
    Date Received
    March 23, 2009
    Report Date
    February 23, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MZV
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). ERRATIC POTASSIUM RESULTS. TO INVESTIGATE THE ISSUE, THE COMPLAINT TEXT, THE BECTON DICKINSON CUSTOMER LETTER, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING WERE REVIEWED. BECTON DICKINSON (BD) RELEASED A CUSTOMER LETTER ON (B)(6), 2008 INFORMING CUSTOMERS IT HAS CONFIRMED ITS BD VACUTAINER BLOOD COLLECTION TUBES CONTAINED SMALL AMOUNTS OF THE HEPARIN CONTAMINANT OVERSULFATED CHONDROITIN SULFATE (OSCS). BASED ON THE LIMITED INFORMATION PROVIDED, IT COULD NOT BE DETERMINED IF THE TUBES UTILIZED MATCHED THE NUMBERS PROVIDED BY BECTON DICKINSON FOR THE PLASMA TUBES TESTED AT THE CUSTOMER'S FACILITY. THE REVIEW SHOWED THE ARCHITECT SYSTEM OPERATIONS MANUAL DOES ADDRESS ERRATIC RESULTS INCLUDING PROBABLE CAUSES AND CORRECTIVE ACTIONS AND INSTRUCTIONS ON COMPONENT REPLACEMENT. IN THE CLINICAL CHEMISTRY INTEGRATED CHIP TECHNOLOGY SODIUM, POTASSIUM, CHLORIDE (ICT NA , K , CL-) REAGENT PACKAGE INSERT, LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. ADDITIONALLY THE REVIEW OF THE INSTRUMENT HISTORY SHOWED NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED INVOLVING ERRATIC RESULTS. THE INVESTIGATION WAS UNABLE TO IDENTIFY THE CAUSE OF THE ISSUE EXPERIENCED AT THE CUSTOMER'S FACILITY. THE MOST PROBABLE CAUSES OF THE ELEVATED POTASSIUM SERUM RESULTS ARE THE PREANALYTICAL FACTORS AND COLLECTION TUBES. PREANALYTICAL CAUSES OF FALSELY ELEVATED POTASSIUM INCLUDE TIGHT TOURNIQUET, EXCESSIVE FIST CLENCHING, DELAY IN CENTRIFUGATION WITH RESULTANT RELEASE OF POTASSIUM FROM CELLULAR ELEMENTS, RELEASE OF POTASSIUM INTO SERUM DURING THE CLOTTING PROCESS FROM PLATELETS DURING THROMBOCYTOSIS OR LEUKOCYTES DURING LEUKOCYTOSIS, AND CONTAMINATION FROM EDTA TUBES THAT WERE COLLECTED BEFORE THE ROUTINE CHEMISTRY TUBE. IF SERUM OR PLASMA IS USED, HEMOLYSIS, WHICH ALSO CAUSES HYPERKALEMIA, COULD OCCUR IN THE COLLECTION TUBE. THE COLLEGE OF AMERICAN PATHOLOGISTS STRONGLY DISCOURAGES THE RECENTRIFUGATION OF GEL-BARRIER TUBES, PARTICULARLY 12 OR MORE HOURS AFTER BLOOD COLLECTION. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS DETERMINED. THE SYSTEM AND/OR ICT MODULE DO NOT APPEAR TO BE THE CAUSE BECAUSE THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS. THE MOST PROBABLE CAUSES OF THE ELEVATED POTASSIUM SERUM RESULTS ARE THE PREANALYTICAL FACTORS AND COLLECTION TUBES. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE OBSERVED DIFFERENCES IN POTASSIUM RESULTS BETWEEN SERUM AND PLASMA SAMPLES TESTED ON THE ARCHITECT C8000. A PATIENT'S SERUM SAMPLE GENERATED A POTASSIUM RESULT OF 7.2 MMOL/L AND WHEN TESTED ON ANOTHER ARCHITECT INSTRUMENT, THE RESULT WAS 7.5 MMOL/L. THE PLASMA SAMPLE FROM THIS PATIENT WAS WITHIN NORMAL RANGE (3.4 - 5.2 MMOL/L). THE SERUM SAMPLE WAS TESTED AT A REFERENCE LABORATORY WITH A RESULT OF >7.2 MMOL/L. THE CUSTOMER STATED THEY REPORT THE PLASMA RESULTS WHEN DISCREPANCIES OCCUR. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER MZV ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE LIST # 9D28-03| ICT MODULE LIST # 9D28-03