BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1820689 · Received August 31, 2010

    Report

    Report Number
    1628664-2010-00319
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MZV
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION INCLUDED A REVIEW OF THE INFORMATION THE CUSTOMER PROVIDED AND THE SYSTEM LOGS FROM BOTH CUSTOMER SYSTEMS (C802488 AND C802479), A REVIEW OF COMPLAINT AND TRENDING DATA, AND A REVIEW OF INFORMATION IN THE ARCHITECT OPERATIONS MANUAL, ICT SERUM CALIBRATOR PACKAGE INSERT, AND ICT SAMPLE DILUENT PACKAGE INSERT. BASED ON THE AVAILABLE INFORMATION, THE DEPRESSED K SLOPES AND LOW K RESULTS THE ACCOUNT EXPERIENCED WERE PROBABLY CAUSED BY A CONTAMINATED OR COMPROMISED ALIQUOT OF LOW CALIBRATOR. HOWEVER, THE CAUSE OF THE CONTAMINATION WAS NOT DETERMINED. THE SAME CALIBRATOR CUPS POURED FROM BOTTLES OF LOT 0311150 WERE USED TO CALIBRATE BOTH OF THE CUSTOMER C8000 SYSTEMS. C802488 WAS CALIBRATED FIRST AND GENERATED A DEPRESSED BUT PASSING K SLOPE OF 57 AND ALSO LOWER QC RESULTS THAT WERE WITHIN THE CUSTOMER QC RANGE. THE LEVEL 1 QC RESULT WAS 1.4 MMOL/L AND THE CUSTOMER ACCEPTABLE RANGE IS 1.3 - 3.3 MMOL/L. THEN CALIBRATION ON C802479 GENERATED A K SLOPE OF 59 AND QC RESULTS OUT OF RANGE LOW. TO RESOLVE THE LOW K SLOPES AND RESULTS THE CUSTOMER RECALIBRATED BOTH SYSTEMS USING FRESH ALIQUOTS FROM THE SAME INITIAL CALIBRATOR BOTTLES OF LOT 0311150. THE SYSTEM LOGS VERIFY THE ISSUE AND REVEAL THAT THE LOW CALIBRATOR MILLIVOLT READINGS FROM THE SUSPECT CALIBRATION DO NOT MATCH THE MILLIVOLT READINGS PERFORMED USING THE FRESHLY POURED CALIBRATOR ALIQUOTS. THE LOGS DO NOT INDICATE ANY PROBLEMS WITH THE C8000 SYSTEMS, AND A REVIEW OF COMPLAINT AND TRENDING DATA DID NOT IDENTIFY AN ADVERSE TREND OR ANY RELATED PRODUCT ISSUES. THE INVESTIGATION TEAM ALSO COMPARED THE ACCOUNT LEVEL 1 QC RANGE (1.3 - 3.3) TO THE K IMPRECISION OF 2.7% CV LISTED IN THE ICT SAMPLE DILUENT PACKAGE INSERT. THE CUSTOMER QC RANGE IS LARGER THAN DESIRED FOR A MEAN OF 2.3 AND CV OF 2.7%, WHICH IS DEMONSTRATED BY USING THE FORMULA MEAN X %CV = SD, OR 2.3 X 2.7/100 = 0.062. THIS FORMULA YIELDS A +/- 3 SD RANGE OF ABOUT 2.1 - 2.5. BASED ON THIS CALCULATED RANGE, A RESULT OF 1.4 WOULD HAVE FAILED LOW, AND TROUBLESHOOTING WOULD BE REQUIRED PRIOR TO RELEASING K RESULTS. RETURNS WERE NOT REQUESTED NOR REQUIRED TO COMPLETE THE EVALUATION. DOCUMENTATION AND SYSTEM LOGS SUPPORT THAT CONTAMINATED ALIQUOTS OF ICT CALIBRATOR CAUSED THE DISCREPANT LOW RESULTS. THE ISSUE WAS RESOLVED WITH FRESH ALIQUOTS OF CALIBRATOR. NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED ARCHITECT POTASSIUM RESULTS WHERE UP TO 6 PATIENTS MAY HAVE RECEIVED POTASSIUM TREATMENT. THE ACCOUNT STATED WHEN THE SPECIMENS WERE REPEATED, THE ARCHITECT POTASSIUM RESULTS WERE IN THE NORMAL RANGE. NO ADDITIONAL PATIENT OR TREATMENT DATA IS AVAILABLE. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THE ARCHITECT ICT MODULE HAD EXPIRED. CUSTOMER SERVICE AND SUPPORT EDUCATED THE ACCOUNT REGARDING THE USE OF EXPIRED ICT MODULES. ADDITIONALLY, THE ACCOUNT STATED THE ORIGINAL ALIQUOT OF CALIBRATOR WAS CONTAMINATED OR COMPROMISED. TWO EXAMPLES OF DATA WERE PROVIDED AS REPRESENTATIVE OF THE FALSELY DEPRESSED PATIENT RESULTS. LABORATORY POTASSIUM NORMAL RANGE 3.5 - 5.4. NO UNITS OF MEASUREMENT WERE PROVIDED. EXAMPLE 2: ARCHITECT POTASSIUM = 2.5, REPEAT 3.7.

    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 Other ICT MODULE LIST 9D28-03