BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2041741 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02045
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 400 MG/DL AND 500 MG/DL ON (B)(6) 2011. SHE DENIED THE PRESENCE OF KETONES; SHE SAID THAT THE PATIENT WAS POSITIVE FOR THIRST AND FREQUENT URINATION. ON (B)(6) 2011, SHE REPORTED THAT THE PATIENT'S BG WAS >500 MG/DL ON (B)(6) 2011; HE WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND TREATED WITH INTRAVENOUS INSULIN FOR 24 HOURS. THE FAMILY MEMBER STATED THAT HE WAS DISCHARGED ON THE SAME PUMP WHICH IS CURRENTLY USED FOR BOLUS DELIVERY ONLY PER HEALTH CARE PROVIDER'S (HCP) RECOMMENDATION. THE PATIENT IS RECEIVING LONG ACTING INSULIN VIA SYRINGE. THE FAMILY MEMBER CONTINUES TO WORK WITH THE HCP TO ADJUST PUMP SETTINGS TO ACCOMMODATE THE PATIENT'S INSULIN NEEDS. SHE REVIEWED THE PUMP AND CONFIRMED THAT THE TIME, DATE, BASAL RATE, AND BOLUS SETTINGS ARE CORRECT. SHE DENIED REDNESS OR MOISTURE AT THE SITE, NO KINKED CANNULAS OR BLOOD IN THE TUBING, AND SHE CHANGES THE SITES APPROPRIATELY. THE FAMILY MEMBER DENIED AIR BUBBLES OR INSULIN LEAKAGE FROM THE CARTRIDGE OR INFUSION SET. SHE CONFIRMED THAT THE BOLUS AND BASAL DELIVERY HISTORY WERE CORRECT; THE BASAL RATES WERE INCREASED BY THE HCP. THE FAMILY MEMBER DENIED ILLNESS, CONFIRMED THAT THE PATIENT IS TEETHING, AND DENIED CHANGES IN MEDICATIONS. SHE SAID THAT THEY DELIVERED CORRECTION BOLUSES VIA THE PUMP AND SYRINGES; THE BG DECREASED WITH SYRINGE-DELIVERED CORRECTIONS BUT NOT WITH THE PUMP CORRECTIONS; THE SAME INSULIN WAS USED IN THE SYRINGE AND PUMP. ALTHOUGH THE FAMILY MEMBER DOES NOT ALLEGE MALFUNCTIONS OR IMPLICATE THE PUMP AS THE CAUSE OF THE BG EXCURSION, THE COMPLAINT IS BEING REPORTED BECAUSE THE CAUSE OF THE HOSPITALIZATION FOR DKA REMAINS UNCLEAR.

    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 17 MO Hospitalization