BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2991333 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02428
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, SHE EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 1.3 MMOL/L. THE PATIENT REPORTEDLY COLLAPSED, WAS HOSPITALIZED AND STATED THAT SHE DOES NOT REMEMBER WHAT OCCURRED. THE PATIENT STATED THAT SHE DID NOT KNOW WHY HER BGS WERE LOW OR WHY SHE COLLAPSED. IT WAS NOTED THAT THE PUMP WAS WORKING FINE AND THAT THE PATIENT WAS STILL USING THE PUMP FOR 2 WEEKS. THE PATIENT REPORTEDLY WAS NOT IMPLICATING THE PUMP AND DENIED TROUBLESHOOTING THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS NOT CLEAR WHAT CAUSED THE PATIENT¿S HYPOGLYCEMIC EVENT OR IF THE PUMP WAS A CONTRIBUTING FACTOR TO THE REPORTED BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95315 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR