BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3021366 · Received March 26, 2013

    Report

    Report Number
    1628664-2013-00066
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (NO CONSEQUENCES OR IMPACT TO PATIENT); (INCORRECT OR INADEQUATE TEST RESULT). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN ELEVATED SODIUM RESULT GENERATED BY THE ARCHITECT C4000 ANALYZER. THE SYSTEM LOG REVIEW INDICATED THAT THE BR2 CONTROL WAS OUTSIDE OF THE DEFINED RANGE. TROUBLESHOOTING CONSISTED OF RECALIBRATION OF THE SODIUM ASSAY. THE QC FOR THE SODIUM CALIBRATION VERIFICATION WAS WITHIN ACCEPTABLE RANGE AND ALL THE PREVIOUS OUT OF RANGE HIGH SODIUM RESULTS WERE RETESTED AND GENERATED NORMAL RESULTS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT C4000 SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT PATIENT SAMPLE (B)(6) GENERATED INITIAL ARCHITECT SODIUM RESULTS OF 166 AND 164 MMOL/L. THE SAMPLE WAS REPEATED AND A RESULT OF 142 MMOL/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124165 ARCHITECT C4000 ANALYZER JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| SN (B)(4)| ARCHITECT ICT MODULE 9D28-03| ARCHITECT ICT MODULE 9D28-03