BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTARII MEDICAL DOSIMETRY SYSTEM

    MDR report key: 18311483 · Received December 12, 2023

    Report

    Report Number
    3008426232-2023-00002
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    December 8, 2022
    Report Date
    December 12, 2023
    Manufacturer
    LANDAUER
    Product Code
    IYE
    PMA / PMN Number
    K192196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO PATIENT 2 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778972 MICROSTARII MEDICAL DOSIMETRY SYSTEM MICROSTARII IYE LANDAUER MICROSTARII

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other