BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2003086 · Received February 8, 2011

    Report

    Report Number
    2531779-2011-00694
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP FELT HOT TO THE TOUCH. SHE STATED THAT SHE FELT THE PUMP DURING THE NIGHT GET VERY HOT TO TOUCH. THE PATIENT NOTED THAT THE SIDE OF THE PUMP NEAR THE BATTERY COMPARTMENT WAS VERY HOT, THE PUMP EMITTED A LOW BATTERY ALARM WHICH WAS CONFIRMED IN THE ALARM HISTORY. THE PATIENT CONFIRMED THAT THE BATTERY SHE WAS USING AT THE TIME OF THE INCIDENT WAS THE ENERGIZER LITHIUM BATTERY THAT WAS SENT WITH THE PUMP KIT; SHE RECEIVED THE PUMP THREE DAYS AGO WHEN SHE BEGAN INSULIN PUMP THERAPY. SHE CONFIRMED THAT THERE WERE NO SIGNS OF MOISTURE OR CORROSION ON THE BATTERY BUT THE BATTERY WAS WARM TO TOUCH. THE PATIENT CHANGED THE BATTERY TO AN ALKALINE BATTERY AND CONTINUED TO USE THE PUMP WITHOUT FURTHER INCIDENTS. THE PATIENT DENIED BODILY INJURY OR BURNS AS A CONSEQUENCE OF THE HEAT.

    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 65 YR