BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3875138 · Received June 16, 2014

    Report

    Report Number
    1628664-2014-00115
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SINGLE PATIENT'S SAMPLES GENERATED LOW SODIUM RESULTS FLAGGED AS < 100 MMOL/L WHEN TESTED WITH ICT MODULE 131209054 ON ARCHITECT C8000 ANALYZER SERIAL NUMBER (B)(4), BUT NORMAL RESULTS (137 MMOL/L) WHEN TESTED WITH A NEW ICT MODULE OR WHEN TESTED ON A DIFFERENT ANALYZER WITH A DIFFERENT ICT MODULE. ICT MODULE 131209054 WAS RETURNED AND THE EXAMINATION FOUND NO VISIBLE DAMAGE. THE (B)(4)RESULT LOG SHOWS ICT MODULE 131209054 GENERATED ERROR 1603 (UNABLE TO CALCULATE RESULT, ICT REFERENCE SOLUTION VOLTAGE DRIFT EXCEEDS 3 MV). THE LOG ALSO SHOWS SOME SODIUM RESULTS WERE FLAGGED PSHH WHICH INDICATES THE ICT SAMPLE RUN IMMEDIATELY BEFORE HAD A CONCENTRATION OUTSIDE THE DYNAMIC OR LINEAR RANGE OR OUTSIDE THE DEFINED EXTREME RANGE WHICH REQUIRES RERUNNING THE SAMPLE TO VERIFY THERE WAS NO EFFECT FROM THE PREVIOUS SAMPLE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ICT SAMPLE DILUENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE AVAILABLE INFORMATION INDICATES THE SODIUM MEMBRANE OF ICT MODULE 131209054 HAD BEEN EXPOSED TO AGING AND AN UNKNOWN CONTAMINANT WHICH INTERACTS WITH AN INTERFERENT/CONTAMINANT UNIQUE TO SAMPLES FROM THE PATIENT IN QUESTION. THE ISSUE WAS RESOLVED BY INSTALLING A DIFFERENT ICT MODULE OR TESTING THE SAMPLES ON A DIFFERENT ICT MODULE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A DECREASED SODIUM RESULT OF <100 MMOL/L WITH A REPEAT OF <100 MMOL/L WAS GENERATED BY THE ARCHITECT C8000 ANALYZER (SN (B)(4)). WHEN THE SAMPLE WAS RUN ON ANOTHER C8000 ANALYZER A RESULT OF 137 MMOL/L WAS GENERATED. THE CUSTOMER STATED THAT ANOTHER SAMPLE FROM THE SAME PATIENT WITH A DIFFERENT COLLECTION DATE ALSO GENERATED A RESULT OF <100 MMOL/L. THE DECREASED RESULTS WERE NOT REPORTED. THE CUSTOMER INDICATED THAT THE ISSUE WAS ONLY SEEN WITH THIS PATIENT. THE CUSTOMER REPLACED THE ICT MODULE AND RERAN THE PATIENT AND A RESULT OF 137 MMOL/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352003 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE 9D28-03| ICT MODULE 9D28-03 LOT 131209054| LOT 131209054