BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1050255 · Received May 22, 2008

    Report

    Report Number
    2531779-2008-00272
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PT EXPERIENCED A HYPOGLYCEMIC EVENT DURING WHICH THE PUMP HISTORY INDICATED THAT MULTIPLE INSULIN BOLUSES WERE ADMINISTERED. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. IF THE DEVICE IS RETURNED, AN EVALUATION 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 RECEIVED EMERGENCY ROOM TREATMENT FOR HYPOGLYCEMIA. THE PUMP HISTORY INDICATED THAT THE PT ADMINISTERED MULTIPLE INSULIN BOLUSES DURING THE HYPOGLYCEMIC EPISODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization