BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1911884 · Received November 23, 2010

    Report

    Report Number
    2531779-2010-02448
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP WAS HOT NEAR THE BATTERY COMPARTMENT. THE PT WAS NOT BURNED OR INJURED. NO CRACKS SEEN ON THE PUMP. THE BATTERY IS AN ENERGIZER LITHIUM BATTERY. NO LEAKAGE OR CORROSION IN THE BATTERY COMPARTMENT. THE BATTERY CAP SECURES TIGHTLY, NO TRAUMA AND NO WATER EXPOSURE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR