BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA-LYSER

    MDR report key: 5895283 · Received August 22, 2016

    Report

    Report Number
    2026994-2016-00001
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 25, 2016
    Report Date
    August 22, 2016
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ON 8-9-2016, INOVA FIELD SERVICE TECH. CONFIRMED THAT COVER SENSOR WAS NOT ACTIVATED AT THE USER'S SITE. THE INSTRUMENT WAS NOT RETURNED TO INOVA. THE USER'S MANUAL CONTAINS MULTIPLE WARNINGS REGARDING USE OF THE INSTRUMENT WHILE IN OPERATION. THERE ARE NO EXPLICIT WARNING SIGNS ON THE INSTRUMENT REGARDING THE USE OF THE INSTRUMENT WHILE IN OPERATION THAT ARE UTILIZED. ON 8-9-2016, INOVA DIAGNOSTICS FIELD SERVICE TECHNICIAN ACTIVATED THE COVER SENSOR ON THE QUANTA-LYSER, S/N (B)(4), AT THE USER'S SITE TO PREVENT OPERATION IF THE COVER IS OPEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR EMPLOYEE WAS LOADING THE QUANTA-LYSER INSTRUMENT WHILE IT WAS RUNNING AND HAD THE HAND IMPALED BY THE PIPETTES. THE TECHNICIAN THAT SUFFERED THE INJURY HAD ALL FOUR SAMPLE PROBES PIERCE HER HAND. SHE HAS BEEN TO THE HOSPITAL BUT ADMISSION STATUS IS UNKNOWN. SHE HAS BEEN PRESCRIBED ANTI-RETROVIRAL MEDICINE AS A PRECAUTION. BLOODBORNE PATHOGEN EXPOSURE INFORMATION IS PENDING. THE QUANTA-LYSER IS AN AUTOMATED BENCH TOP BATCH PROCESSOR DESIGNED FOR PERFORMING AUTOMATICALLY VARIOUS STEPS SUCH AS PIPETTING, MEASURING COLOR INTENSITY, ETC. FOR USE WITH ENZYME IMMUNOASSAYS, ELISA AND IMMUNOFLUORESCENT ASSAY TECHNOLOGIES. THE QUANTA-LYSER HAS A BUILT-IN CAPABILITY TO PREVENT OPERATION IF THE FRONT COVER IS OPEN. IT IS REFERENCED IN THE USER MANUAL IN THE PRECAUTIONS SECTION. THE COVER SENSOR FUNCTIONALITY IS INACTIVE BY DEFAULT AND MUST BE ACTIVATED BY AN INOVA FIELD SERVICE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544554 QUANTA-LYSER CHEMISTRY ANALYZER FOR CLINICAL USE JJE INOVA DIAGNOSTICS, INC. 240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other