BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1952689 · Received January 4, 2011

    Report

    Report Number
    2531779-2011-00012
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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

    A FAMILY MEMBER REPORTED THAT THE BATTERY AND PUMP BECAME WARM TO THE TOUCH. SHE STATED THAT THE PT COMPLAINED THAT HER ABDOMEN FELT WARM. THE FAMILY MEMBER SAID THAT SHE PICKED UP THE PUMP WHICH FELT HOT TO TOUCH; THE PT'S SKIN APPEARED RED, BUT IF DID NOT LOOK BURNED. THE FAMILY MEMBER CONFIRMED THAT THE BATTERY WAS WARM TO TOUCH; SHE SAID THE BATTERY AND PUMP WAS NOT HOT ENOUGH TO BURN HER HAND WHEN SHE HANDLED THEM. THIS TIME WAS THE FIRST INCIDENT WHEN THE PUMP FELT WARM. SHE NOTED THAT PRIOR TO THE COMPLAINT OF HEAT, THE PUMP EMITTED A LOW BATTERY WARNING. THE FAMILY MEMBER SAID THEY USE 1.5 VOLT AA LITHIUM ULTIMATE ENERGIZER BATTERIES AND THE PUMP IS SET FOR LITHIUM. SHE DENIED MOISTURE OR CORROSION IN BATTERY COMPARTMENT, AND BATTERY CAP IS INTACT.

    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 9 YR