BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEVO TQ-S

    MDR report key: 3181457 · Received June 14, 2013

    Report

    Report Number
    9616673-2013-00001
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    WATERS CORPORATION
    Product Code
    DOP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE REPORTED INACCURATE RESULTS WERE RELATED TO THE CUSTOMER'S HANDLING OF THE DATA, NOT AN ISSUE WITH THE INSTRUMENT OR THE RESULTS THAT WERE GENERATED. A WATERS INVESTIGATION INTO THE ISSUE FOUND THAT NO DEVICE FAILURE HAD OCCURRED. THE CUSTOMER HAD SELECTED "UPDATE RETENTION TIMES" IN THE SOFTWARE, WHICH AUTOMATICALLY SELECTS THE LARGEST PEAK IN THE TRACE WHEN MULTIPLE PEAKS ARE PRESENT. THE EMBEDDED HELP FILE FOR THE INSTRUMENT'S SOFTWARE STATES, "WHEN UPDATING RETENTION TIMES, THE RETENTION TIME OF THE PEAK WITH THE BIGGEST AREA ON THE TRACE USED BY HIS COMPOUND IS USED TO UPDATE THE RETENTION TIME IN THE METHOD. IF MORE THAN ONE COMPOUND USES THE SAME TRACE, THEN THE BIGGEST PEAKS ON A TRACE ARE ASSIGNED TO COMPOUNDS IN THE METHOD IN THEIR RELATIVE RETENTION TIME ORDER." BASED ON THE CUSTOMER'S METHOD, MULTIPLE PEAKS WOULD BE EXPECTED IN THEIR TRACE. BY SELECTING "UPDATE RETENTION TIME," THE CUSTOMER SET THE SOFTWARE TO SELECT THE LARGEST PEAK IN THE TRACE, WHICH IN THIS CASE WAS NOT THE CUSTOMER'S PEAK OF INTEREST. THE INSTRUMENT PERFORMED AS EXPECTED. THE ISSUE WAS WITH THE DATA SELECTED BY THE CUSTOMER, NOT THE ACCURACY OF THE RESULTS GENERATED BY THE INSTRUMENT. NO ADVERSE PATIENT REACTIONS WERE REPORTED AND THERE IS NO INDICATION THAT PATIENT THERAPIES WERE ALTERED AS A RESULT OF THE REPORTED RESULTS. TRAINING REGARDING USE OF THE INSTRUMENT AND ITS SETTINGS WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THEY HAVE MODIFIED THEIR DATA REVIEW PROCEDURE. WE CONSIDER THIS REPORT TO BE COMPLETE. HOWEVER, IF ADDITIONAL RELEVANT INFORMATION IS REPORTED, WE WILL SUBMIT A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER: ON (B)(6) 2013 THE CUSTOMER REPORTED THAT THE WRONG PEAK WAS BEING SELECTED IN SAMPLES, RESULTING IN INCORRECT RESULTS BEING REPORTED. THE CUSTOMER PERFORMS OPIOID SCREENING AND PAIN MANAGEMENT MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271559 XEVO TQ-S DOP MASS SPECTROMETER, CLINICAL USE DOP WATERS CORPORATION XEVO TQ-S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention