BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS IR 2020

    MDR report key: 1374445 · Received May 3, 2009

    Report

    Report Number
    MW5010952
    Event Type
    Injury
    Date Received
    May 3, 2009
    Date of Event
    April 24, 2009
    Report Date
    May 3, 2009
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY ANIMAS 2020 IR INSULIN PUMP FAILED AND GAVE ME 200 UNITS OF HUMALOG INSULIN. I WAS TAKEN BY AMBULANCE TO HOSPITAL AROUND 4 AM AFTER MY MOTHER FOUND ME UNCONSCIOUS IN MY BED. WHEN SHE RIPPED MY INFUSION SET OUT, MY INSULIN PUMP WAS ALARMING THAT I WAS OUT OF INSULIN. I HAD FILLED THE NEW CARTRIDGE WITH 208 UNITS OF HUMALOG AT 12 AM. WHEN SHE CHECKED MY BLOOD SUGAR, IT WAS "LO" ON THE METER. FROM THE HOSPITAL, I WAS TAKEN BY AMBULANCE TO MEDICAL CENTER WHERE I SPENT 3 DAYS IN THE ICU. IN 2009, I WAS TRANSFERRED BY AMBULANCE TO ANOTHER MEDICAL CTR, WHERE I AM INPATIENT UNTIL EARLY THE FOLLOWING MONTH, WHEN I WAS RELEASED. I CONTACTED ANIMAS CORPORATION TODAY AND I WAS TOLD TO FILE A COMPLAINT WITH THE FDA. DATES OF USE; 2009. DIAGNOSIS: DIABETES MELLITUS - TYPE 1. EVENT ABATED AFTER USE: YES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS IR 2020 ANIMAS 2020 LZG ANIMAS CORP 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| S