BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1941801 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03010
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    September 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE EXPERIENCED HYPOGLYCEMIA AND UNCONSCIOUSNESS WITH NO FOREWARNING. SHE STATED THAT HER BLOOD GLUCOSE WAS MEASURED BY EMERGENCY MEDICAL TEAM AT 20 MG/DL. THE PT REPORTED THAT SHE WAS GIVEN GLUCAGON THREE TIMES BY THE EMT PERSONNEL. SHE NOTED THAT SHE DOES NOT REMEMBER SIX HOURS OF THAT DAY AND ALLEGED THE REASON TO BE THE HYPOGLYCEMIA. THE PT SAID SHE DOES NOT REMEMBER HER BLOOD GLUCOSE LEVELS PRIOR TO EVENT, SHE REMEMBERS EATING BUT THERE ARE NO BOLUSES RECORDED IN THE BOLUS HISTORY TO CONFIRM. SHE STATED THAT SHE DOES NOT REMEMBER ANY UNUSUAL ACTIVITY OR CHANGE OF MEDICATIONS PRIOR TO THE EVENT. IT WAS NOTED THAT THE PT IS A POOR MEDICAL HISTORIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention