BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3170121 · Received June 14, 2013

    Report

    Report Number
    2531779-2013-08236
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 REPORTER CONTACTED ANIMAS STATING THE METER READ ¿HIGH¿. THE PATIENT REPORTEDLY EXPERIENCED NAUSEA, STOMACH PAIN AND VOMITING. THE HEALTH CARE PROVIDER (HCP) INSTRUCTED THE REPORTER TO TREAT THE PATIENT WITH CORRECTION INJECTIONS. IT WAS NOTED THAT THE HCP INSTRUCTED THE REPORTER TO HAVE THE PATIENT DISCONTINUE THE USE OF THE PUMP AND TO HAVE THE PATIENT GO ON A BACK-UP PLAN. THE PATIENT¿S BG REPORTEDLY WENT DOWN TO 149MG/DL AFTER BEING TREATED WITH CORRECTION INJECTION. THERE WAS NO INDICATION OF A SITE/SET ISSUE. IT WAS NOTED TROUBLESHOOTING COULD NOT BE PERFORMED DUE TO AN UNRELATED ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE INSULIN PUMP THERAPY. IT WAS UNKNOWN WHAT THE CONTRIBUTING FACTORS WERE FOR THE PATIENT'S BG EXCURSION AND WHETHER OR NOT THE PUMP WAS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271788 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR