BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1982714 · Received February 3, 2011

    Report

    Report Number
    2531779-2011-00631
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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

    A PUMP EDUCATOR NURSE FROM THE HOSPITAL CONTACTED ANIMAS TO REPORT AN INCIDENT THAT OCCURRED WITH THE PT. THE REPORTER STATED THE PT'S BLOOD GLUCOSE (BG) WAS 79 MG/DL WHEN SHE WOKE UP YESTERDAY MORNING. THE PT THEN ATE A "SMALL" AMOUNT OF FOOD AND THEN TOOK 0.5 UNITS OF BOLUS INSULIN TO COVER HER FOOD. AT AN UNSPECIFIED TIME, THE PT STARTED TO FEEL NAUSEATED, VOMITED, AND HAD JAW PAIN. THE PT'S SISTER CONTACTED 911 AND WHEN THEY ARRIVED, THE PT'S BG WAS 400-500 MG/DL. ACCORDING TO THE REPORTER, A CARDIAC ISSUE WAS RULED OUT. THE REPORTER STATED THAT THE PT CLAIMED THE INFUSION SET APPEARED TO BE STRAIGHT WHEN IT WAS REMOVED FROM THE INSERTION SITE. THE PT REPORTEDLY HAS NOT HAD RECENT CHANGES TO HER DIET, HEALTH, MEDICATIONS, OR ACTIVITY LEVELS. DETAILS ABOUT THE PT'S TREATMENT WERE NOT PROVIDED. THE ANIMAS REP WENT THROUGH THE TROUBLESHOOTING WITH THE REPORTER AND NOTED THE FOLLOWING: THERE WERE NO ASSOCIATED ALARMS IN THE PUMP'S HISTORY, THE PUMP WAS NOT SUSPENDED, THERE WAS NO EVIDENCE OF AIR BUBBLES/LEAKING IN THE INFUSION SET TUBING, TOTAL DAILY DOSAGES FOR THE PAST WEEK AND THE PUMP SETTINGS WERE CONFIRMED TO BE CORRECT, THE INSULIN WAS IN GOOD CONDITION. ACCORDING TO THE ANIMAS REP INVOLVED WITH THE REPORTER, THERE WAS NO INDICATION OF A PUMP MALFUNCTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY DEVELOPED ELEVATED BLOOD GLUCOSE LEVELS WITH VOMITING AND RECEIVED MEDICAL ASSISTANCE FROM HEALTH CARE PROFESSIONALS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Life Threatening| H