BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO

    MDR report key: 6111419 · Received November 17, 2016

    Report

    Report Number
    2517506-2016-00448
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 17, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGANOSTICS INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER OBSERVED THE DISCORDANT RESULTS WERE OBTAINED WHEN SAMPLED FROM THE APTIO AUTOMATION TRACK AND NOT WHEN FRONT LOADED ON THE INSTRUMENT. CCC REVIEWED THE INSTRUMENT DATA AND FOUND NO ERRORS IN THE ERROR LOGS. QUALITY CONTROLS (QC) WERE WITHIN RANGE WHEN THE EVENT OCCURRED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE FOUND AN ERROR ON THE APTIO FOR THE GRIPPER. THE CSE RESET THE WIRING FOR THE PNEUMATIC FINGERS FOR THE APTIO GRIPPER, VERIFIED THE ALIGNMENTS AND REBOOTED THE NODE AND RESET IT. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, CA, K,CL, AND GLU RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM (NA), CALCIUM (CA), POTASSIUM (K), CHLORIDE (CL) AND GLUCOSE (GLU) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT CONNECTED WITH AN APTIO AUTOMATION SYSTEM TRACK. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING HIGHER AND WITHIN THE EXPECTED RANGE. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NA, CA, K,CL, AND GLU RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760962 APTIO LABORATORY AUTOMATION SYSTEM JJE SIEMENS HEALTHCARE DIAGANOSTICS INC. APTIO

    Patients

    Seq Age Sex Outcome Treatment
    1