BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1153262 · Received September 8, 2008

    Report

    Report Number
    2531779-2008-00543
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    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 PATIENT REPORTED THAT HE REGULARLY EXPERIENCES ERRATIC BLOOD GLUCOSE LEVELS. THE PATIENT ALSO REPORTED THAT HE DOES NOT ROUTINELY SEE A PHYSICIAN AND "SELF-REGULATES" HIS BLOOD GLUCOSE AND INSULIN DOSAGES. 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 PATIENT EXPERIENCED HYPOGLYCEMIA FOR WHICH GLUCAGON WAS ADMINISTERED. THE PATIENT REPORTED THAT HE REGULARLY EXPERIENCES ERRATIC BLOOD GLUCOSE LEVELS. THE PATIENT ALSO REPORTED THAT HE DOES NOT ROUTINELY SEE A PHYSICIAN AND "SELF-REGULATES" HIS BLOOD GLUCOSE AND INSULIN DOSAGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention