BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2050012-2016-00321

    MDR report key: 6084228 · Received November 7, 2016

    Report

    Report Number
    2050012-2016-00321
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 31, 2016
    Report Date
    October 31, 2016
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT SENT TO THE CUSTOMER SITE. WORKING ON THE PHONE WITH BEC CUSTOMER TECHNICAL SUPPORT, THE CUSTOMER FLUSHED THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE TO RESOLVE THE ISSUE. THE CUSTOMER STATED THERE WAS RESISTANCE WHILE FLUSHING THE PROBE, WHICH IS INDICATIVE OF A SAMPLE RELATED OBSTRUCTION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNICEL DXC UNICEL DXC 800 PRO SYNCHRON SYSTEM GENERATED A FALSE LOW PHENYTOIN (PHY) RESULT ON ONE PATIENT SAMPLE AND WAS REPORTED OUT OF THE LABORATORY. AFTER ROUTINE CONTROLS RECOVERED LOW, PATIENT SAMPLES WERE RERUN ON AN ALTERNATE DXC AND THE LOW PHENYTOIN WAS DISCOVERED. THE PATIENT RECEIVED A DOSE OF PHENYTOIN BASED UPON THE FALSE LOW RESULT, BUT THERE IS NO INDICATION THAT THE PATIENT WAS HARMED FROM THE EXTRA DOSE OF PHENYTOIN. THE REPORT WAS AMENDED WITH THE HIGHER RESULT FROM THE OTHER DXC INSTRUMENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other