MAUDE Adverse Event Report: LANDAUER MICROSTARII MEDICAL DOSIMETRY SYSTEM

Model Number MICROSTARII

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

• Brand Name: MICROSTARII MEDICAL DOSIMETRY SYSTEM
• Type of Device: MICROSTARII
• Manufacturer (Section D): LANDAUER; 2 science road; glenwood IL 60425 1586
• Manufacturer Contact: harish vishwanathan ; 2 science road; glenwood, IL 60425-1586 ; 3127228534
• MDR Report Key: 18311420
• MDR Text Key: 330288743
• Report Number: 3008426232-2023-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K192196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MICROSTARII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other