BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 14467925 · Received May 23, 2022

    Report

    Report Number
    3003442380-2022-00688
    Event Type
    Injury
    Date Received
    May 23, 2022
    Report Date
    May 23, 2022
    Product Code
    FPA
    UDI-DI
    05705244020337
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON HAD VOMITING DUE TO A BENT CANNULA. THIS ISSUE OCCURRED TWICE. THE FIRST INFUSION SET WAS LAST CHANGED ON (B)(6) 2022, BUT HIS BLOOD GLUCOSE LEVEL WENT HIGH APPROXIMATELY 20 MMOL/L, SO HIS MOTHER REMOVED AND CHANGED THE SET IN MIDDLE OF NIGHT. THE SITE LOCATION WAS HIS ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR LESS THAN 12 HOURS. CONSEQUENTLY, ON (B)(6) 2022 AT 5:00 PM, HE VISITED THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, HE WAS ADMINISTERED INSULIN DRIP, SOME UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AND INSULIN DRIP. HE WAS RELEASED AFTER 18 HOURS. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 4.2 MMOL/L. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522091 MIO UNO INSET II 60/6 SC1 BLUE MCAN FPA MMT-943A600 5355968 05705244020337

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown