BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2994289 · Received March 8, 2013

    Report

    Report Number
    2531779-2013-02507
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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 CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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 CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT HER BLOOD GLUCOSE (BG) YESTERDAY EVENING WAS 190MG/DL AND FROM THAT TIME THE BG CONTINUED TO ELEVATE TO 550MG/DL EVEN AFTER SUCCESSFUL BOLUSES. THE PATIENT REPORTS NO SPECIFIC SYMPTOMS BUT DOES NOT FEEL WELL AND IS UNABLE TO DETERMINE IF ITS FROM ELEVATED BG OR OTHER MEDICAL ISSUES. THE PATIENT STATED THAT SHE WAS CURRENTLY IN THE HOSPITAL FOR UNKNOWN MEDICAL ISSUE AND DENIED THAT IT WAS DIABETES RELATED. THE PATIENT STATED THAT YESTERDAY EVENING SHE DID NOT COVER FOR HER CARBOHYDRATES EATEN AT DINNER. CUSTOMER SUPPORT ADVISED THE PATIENT TO REMAIN OFF THE PUMP UNTIL REPLACEMENT PUMP ARRIVES. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100176 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening