BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1912700 · Received November 26, 2010

    Report

    Report Number
    2531779-2010-02568
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. THE PUMP WAS PLACED IN THE LOCKED POSITION AND NO UNPROGRAMMED BOLUSES WERE DELIVERED OR RECORDED IN THE PUMP HISTORY. WITH THE PUMP LOCKED THE BOLUS SCREEN WAS UNABLE TO BE ACTIVATED. NO STICKING OR HYPERTENSIVE BUTTONS WERE OBSERVED.

    Description of Event or Problem · 1

    THE PT'S PARENTS REPORTED THAT THE PT EXPERIENCED HYPOGLYCEMIA (33MG/DL) WHILE AT SCHOOL. THE PT WAS TREATED BY THE SCHOOL NURSE WITH JUICE AND SODA. THE PUMP HISTORY INDICATES MULTIPLE BOLUSES WERE PERFORMED TOTALING 48 UNITS. THE PT'S PARENTS INDICATED THAT THE PUMP WAS LOCKED, BUT THE PT KNOWS HOW TO UNLOCK THE PUMP.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention