BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1962730 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00084
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS FOR INVESTIGATION INTO THIS COMPLAINT. THE PT DECLINED PUMP TROUBLESHOOTING AND STATED THAT THE REASON HER BLOOD GLUCOSE LEVEL WAS HIGH WAS THAT SHE FORGOT A BOLUS DOSE.

    Description of Event or Problem · 1

    THE PT MENTIONED HE WAS ADMITTED TO THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVELS. SHE NOTICED A CRACK IN THE BATTERY COMPARTMENT BUT CONFIRMED THAT THE PUMP DID NOT LOSE POWER. SHE REPORTED THAT SHE FORGOT TO BOLUS HER INSULIN AND HER BLOOD GLUCOSE LEVELS ROSE AFTERWARD. SHE WAS DISCHARGED FROM THE HOSP A DAY AFTER SHE WAS ADMITTED AND HER BLOOD GLUCOSE LEVELS WHEN ON THE PHONE WITH ANIMAS WAS 282 MG/DL. HER BLOOD GLUCOSE LEVEL WAS 344 MG/DL BEFORE CALLING ANIMAS AND WAS DECREASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R