BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 10267424 · Received July 13, 2020

    Report

    Report Number
    1219029-2020-00040
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    June 26, 2020
    Report Date
    July 13, 2020
    Product Code
    PZI
    UDI-DI
    00385480449939
    PMA / PMN Number
    K181043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO NOVA AND NO SERIAL NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATE: "WARNING: DO NOT STARE INTO THE LASER LIGHT OR POINT IT TOWARDS ANYONE'S EYES WHILE SCANNING A BARCODE." MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER; THERE WAS NO RESPONSE. THIS COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO NOVA FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO INQUIRE ABOUT ANY DANGERS IMPOSED BY THE BEAM OF THE BARCODE SCANNER IN STATSTRIP GLUCOSE HOSPITAL METER PN 44993. A USER LOOKED INTO THE SCANNER OF A STATSTRIP METER. CUSTOMER REPORTED THEIR EYES HURT AND STARTED SEEING BLACK SHAPES. CUSTOMER WENT TO SEE THE HOSPITAL'S MEDICAL OFFICER TO REPORT THE EVENT AND SEEK CONSULTATION. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE SPECIFIC RESULTS AND OR PATIENT SPECIFIC INFORMATION, HOWEVER; NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729104 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM BLOOD GLUCOSE METER PZI 44933 00385480449939

    Patients

    Seq Age Sex Outcome Treatment
    1