BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1931042 · Received December 8, 2010

    Report

    Report Number
    2531779-2010-02793
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT'S MOTHER AND PT CONTACTED ANIMAS TO REPORT THE FOLLOWING: THE PT'S BLOOD GLUCOSE REPORTEDLY HAD BEEN EVALUATED FOR THE PAST 3 WEEKS: LAST EVENING, BLOOD GLUCOSE WAS 480 MG/DL WITH KETONES AND THE PT'S CURRENT BLOOD GLUCOSE DURING THE CALL AS 296 MG/DL. THE PT IS NOT ON NEW MEDICATIONS AND ROTATES INFUSION SET SITES. THE PT HAD BEEN USING THE INSET 9MM INFUSION SET FOR THE PAST 4 YRS AND CLAIMED THERE IS AN ISSUE WITH THE INSULIN LEAKING AT THE SITE AREA: THE DATE OF THE MOST RECENT OCCURRENCE OF THE INSULIN LEAKING WAS NOT PROVIDED. THE ANIMAS REP WENT THROUGH TROUBLESHOOTING WITH THE RPTR AND NOTED THE FOLLOWING: THE CANNULA REPORTEDLY WAS NOT BENT AND THE PUMP HISTORY WAS CONFIRMED TO BE CORRECT. THE ANIMAS REP DID NOT NOTE ANY PUMP MALFUNCTIONS. IT WAS NOTED THAT THE PT BOLUS LARGE AMOUNTS OF INSULIN, SO THE PT WAS ADVISED TO CHANGE THE BOLUS DELIVERY TO THE SLOW SETTING TO SEE IF THAT WOULD MAKE A DIFFERENCE. THE ANIMAS REP CONDUCTED A F/U WITH THE PT ON (B)(6), 2010. THE PT INDICATED THERE HAS NOT BEEN ANY LEAKING AT THE SITE AFTER THE BOLUS DELIVERY HAD BEEN CHANGED TO THE SLOW SETTING. THE PT'S BLOOD GLUCOSE LEVELS ARE STILL ELEVATED AND THE PT IS STILL IN CONTACT WITH THE HEALTH CARE PROFESSIONAL WITH MANAGING THE ELEVATED BLOOD GLUCOSE LEVELS. THIS IS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R