Landauer performed a thorough investigation and landauer currently has no information leading it to conclude that there was serious injury or death.Nor does landauer have information indicating the device in question malfunctioned.Out of abundance of caution, landauer is reporting this incident to fda.Information provided to landauer by the customer led landauer to concluded that the customer who reported the incident did not follow the daily quality control procedures outlined in the ifu, resulting in dust accumulation and calibration value drift.Additionally, the device was used off label as the primary device to check the patient dose, contrary to the recommendations in the microstarii ifu, which specifies it as a secondary dose verification system and not for making direct patient care decisions.Thus, the investigation found that failure to follow instructions and off label use of the product resulted in the reported over exposure.France's regulatory body, autorité du sûreté nucléaire (asn), conducted an investigation and categorized this event as level 2+ on the asn-sfro scale of radiotherapy events, which ranges from 0 to 7 in order of increasing severity.A level 2 incident on the asn sfro scale refers to "moderate, unexpected, or unpredictable acute or late effects of grade 2, with minimal or no deterioration in quality of life." if any new, relevant information is received, landauer will supplement this report.
|
This report pertains to pateint 6 out of 6.On december 8th, 2022, a customer in lyon, france reported concerns about the calibration value drift after the instrument was recalibrated.As a result, the reporter alleged that there was radiation overexposure to 6 patients.This complaint is registered in landauer complaint system under complaint#(b)(4).
|