BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00360

    MDR report key: 6897709 · Received September 27, 2017

    Report

    Report Number
    1628664-2017-00360
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 27, 2017
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF TICKETS DID NOT IDENTIFY AN INCREASE IN COMPLAINTS RELATED TO FALSELY ELEVATED POTASSIUM (K) RESULTS AND NO TRENDS FOR THE CUSTOMER'S REPORTED ISSUE FOR THE ICT DILUENT, LOT 60311UN17. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE CUSTOMER REPORTED THAT THE SAMPLE WAS NOT HEMOLYZED. A REVIEW OF LABELING WAS FOUND TO ADEQUATELY ADVISE THE CUSTOMER ON ICT SAMPLE ANALYSES INCLUDING: SAMPLE PREPARATION, TROUBLESHOOTING AND RESOLUTION OF RESULTS RELATED ISSUES. THE ARCHITECT C803168 LOGS WERE REVIEWED AND MULTIPLE ERROR CODE 3375 [ASPIRATION ERRORS] WERE NOTED TO HAVE OCCURRED CLOSE TO THE SUSPECT POTASSIUM RESULTS. ERROR CODE 3375 IS GENERATED BY THE INSTRUMENT WHEN AN ASPIRATION ERROR OCCURS ON A SAMPLE, SUGGESTING THAT THE SAMPLE WAS INSUFFICIENTLY PREPARED PRIOR TO ANALYSIS. BASED ON SAMPLE CALCULATIONS PERFORMED BY THE INSTRUMENT DURING MEASUREMENT, THE ICT REFERENCE SOLUTION MEASUREMENTS BEFORE AND AFTER THE SUSPECT SAMPLE POTASSIUM MEASUREMENT, ARE STABLE. THE SAMPLE SHOWS A HIGHER THAN EXPECTED SAMPLE READ VOLTAGE. BASED ON THE COMPLAINT DATA AND THIS INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR ICT DILUENT, LOT 60311UN17 OR THE ARCHITECT C803168 ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM (K) RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL 6.5/ REPEATED = 4 AND 4 / RUN 10X = 4 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1