BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 18473983 · Received January 9, 2024

    Report

    Report Number
    3003442380-2024-00001
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    October 6, 2023
    Report Date
    January 25, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014572
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO USED OR UNSED SAMPLES HAVE BEEN RETURNED, AND THE LOT NUMBER IS UNKNOWN, UNOMEDICAL CANNOT PERFORM FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    UNOMEDICAL REF.(B)(4). DIABETIC PATIENT HAS EXPERIENCED ON (B)(6) 2023, A HIGH BLOOD GLUCOSE OF 1000 MG/DL. PATIENTS' WIFE CALLED 911 WHEN PATIENT LOST CONSCIOUSNESS AND HAD INJURY IN THE LOWER BACK BY FALLING. UNOMEDICAL A/S HAS REQUESTED HOSPITALIZATION INFORMATION REGARDING THIS INCIDENT, BUT THE PROVIDED INFORMATION DID NOT DEFINE SPECIFICALLY HOW LONG THE PATIENT WAS IN A COMA OR IF IT WAS A COMA OR JUST LOSS OF CONSCIOUSNESS. THE PATIENT SUSPECT FALL OF INFUSION SET TAP TO BE A PROBABLE CAUSE FOR HIGH BG. HCP STATED THAT THE PATIENT HAS A CONGESTIVE HEART FAILURE. NO OTHER CONSEQUENCES OR PERMANENT DAMAGE TO PATIENT BODY STRUCTURE OR FUNCTION ARE REPORTED. NO MORE INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650527 AUTOSOFT 90 INSULIN INFUSION SET FPA UNOMEDICAL A/S 1000282 UNKNOWN 05705244014572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H