BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1926073 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02451
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE "DOWN" AND "OK" BUTTONS HAVE TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE AND CLEANING PRODUCTS. ALL OF THE BUTTONS BOUNCE AND SPRING BACK NORMALLY.

    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 13 YR