BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2987067 · Received March 4, 2013

    Report

    Report Number
    1628664-2013-00041
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER'S ISSUE SHOWED THAT THE CUSTOMER HAD INSTALLED THE ICT MODULE WITH AN EXTRA O RING ON ONE SIDE OF THE ICT MODULE. THE ARCHITECT OPERATIONS MANUAL LISTS INCORRECT PLACEMENT OF O RINGS AS A LIKELY CAUSE OF ERRATIC ICT RESULTS. FURTHERMORE, THE INSTRUMENT LOGS INDICATED ERRORS CONSISTENT WITH INCORRECT PLACEMENT OF O RINGS AROUND THE TIME OF THE OCCURRENCE OF THE ISSUE DESCRIBED IN THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY WAS NOT IDENTIFIED. THERE IS NO EVIDENCE THAT A MALFUNCTION OCCURRED AS THE ICT MODULE HAD BEEN IMPROPERLY INSTALLED WITH AN EXTRA O-RING. CURRENT LABELING PROVIDES INSTRUCTIONS FOR REPLACEMENT OF THE ICT MODULE AND TROUBLESHOOTING ASSISTANCE FOR ERROR CODES GENERATED AND ERRATIC RESULTS. COMPLAINT INFORMATION REASONABLY SUGGESTS THAT THE INSTRUMENT IS PERFORMING AS INTENDED AND NO MALFUNCTION OF THE DEVICE OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. CORRECTED THE BIRTH YEAR OF THE PATIENT FROM "2944 " TO "1944."

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT C8000 ANALYZER. THE SODIUM SAMPLE FROM FEMALE PATIENT DATE OF BIRTH (B)(6) 2944 SID (B)(6) WAS DRAWN ON (B)(6), 2013. ON (B)(6) THE SAMPLE WAS MEASURED WITH RESULTS OF 108 AND 110 MMOL/L. A VERIFICATION OF THE RESULTS ON ANOTHER ARCHITECT (C4000, LKH JUDENBURG) PRODUCED A VALUE OF 142 MMOL/L. ON (B)(6), AFTER REPLACING THE ICT MODULE, IT PRODUCED RESULTS OF 145 AND 145 MMOL/L. ON (B)(6), A NEW SAMPLE WAS DRAWN FROM THE SAME FEMALE PATIENT (SID: (B)(6)). THE SAMPLE WAS MEASURED BEFORE THE ICT MODULE WAS REPLACED (108 MMOL/L) AND AGAIN AFTER (139 MMOL/L). THE FOLLOWING WAS NOTED: IN THE LAST CALIBRATION THERE WAS AN INCREASE OF 64.7% IN NA, 93.7 % IN K AND 71.3 % IN CL. THE CUSTOMER RETURNED THE ICT MODULE, AND IT WAS INSPECTED BY ABBOTT WHO FOUND 2 SEAL RINGS ON ONE SIDE (THE SIDE FACING THE ICT PROBE). THE ICT MODULE WAS INSTALLED ON (B)(6) 2012 AT 11:18 AM. AT THAT TIME ERROR "5619 ICT OFFSET 11:18 AM ADJUSTMENT ERROR FOR NA)" OCCURRED TWICE (11:21 AM AND 11:28 AM). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91033 ARCHITECT C8000 SYSTEM JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ICT MODULE LN (B)(4) SODIUM| ICT MODULE LN (B)(4) SODIUM