BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3171024 · Received June 14, 2013

    Report

    Report Number
    2531779-2013-08254
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 NURSE CONTACTED ANIMAS STATING THAT THE PATIENT WAS IN DIABETIC KETOACIDOSIS (DKA) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 24 MMOL/L WITH NAUSEA, VOMITING AND MODERATE KETONES. THE NURSE STATED THAT THE PUMP EMITTED MULTIPLE OCCLUSION ALARMS AND THERE WAS NO INDICATION OF A SITE/SET OR CARTRIDGE ISSUE. IT WAS NOTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND WAS BEING TREATED WITH ANTIBIOTICS. THE NURSE STATED THE PATIENT USED THE VIBE PUMP BUT WAS UNABLE TO VERIFY THE SERIAL NUMBER. THE PATIENT REPORTEDLY DID NOT HAVE ISSUES WITH OTHER PUMPS AND THE NURSE WANTED THE PUMP REPLACED. THE PUMP AND THE PATIENT WERE REPORTEDLY UNAVAILABLE TO TROUBLESHOOT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THERE MAY HAVE BEEN A PUMP MALFUNCTION. USE ERROR MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED EVENT BECAUSE THE PATIENT MAY NOT HAVE BEEN RESPONDING TO ALARMS APPROPRIATELY EMITTED BY THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271453 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R