BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1913066 · Received July 29, 2010

    Report

    Report Number
    2531779-2010-00793
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 29, 2010
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS FOR INVESTIGATION. IF THE PUMP IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PT HAD RECENTLY BEEN TRAINED ON HOW TO USE THE PUMP AND IS WORKING WITH THE CDE TO ADJUST HER TECHNIQUE FOR INSERTING THE INFUSION SET AND SETTING THE CARTRIDGE. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization