BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1962718 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00175
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REPORTED THAT HE ADMINISTERED EXCESS INSULIN BY PUSHING ON THE CARTRIDGE PLUNGER WHILE ATTACHED TO THE INFUSION SET. THE USER GUIDE CAUTIONS THE USER TO FOLLOW INSTRUCTIONS IN ORDER TO AVOID IMPROPER OR INCORRECT USE OF THE PUMP. USING THE CARTRIDGE OUTSIDE OF THE PUMP IS NOT A RECOMMENDED METHOD OF INSULIN DELIVERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED HYPOGLYCEMIA THAT WAS TREATED BY PARAMEDICS. THE PT SAID THAT HIS WIFE CALLED FOR PARAMEDICS BECAUSE HIS BLOOD GLUCOSE READING DISPLAYED "LOW" ON THE METER. HE SAID THAT THE PARAMEDICS REMOVED THE PUMP AND HIS BLOOD GLUCOSE RESOLVED TO 200 MG/DL AFTER TREATMENT. THE PT NOTED THE FOLLOWING SEQUENCE OF EVENTS: HE ATE DINNER AROUND 7:30 PM, THE CARTRIDGE NEEDED TO BE REPLACED, HE REMOVED THE CARTRIDGE FROM THE PUMP, AND MANUALLY PUSHED ON THE PLUNGER TO DELIVER HIS DINNER BOLUS. HE SAID HE WAS NOT AWARE OF HOW MANY UNITS WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200/1250/2020/OTP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention