BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1944372 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03121
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THERE IS NO EVIDENCE OF A PUMP MALFUNCTION AT THIS TIME AND TROUBLESHOOTING DEMONSTRATED THAT THE PUMP WAS DELIVERING INSULIN AS PROGRAMMED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PT'S DOCTOR WANTED THE PUMP REPLACED BECAUSE HIS BLOOD GLUCOSE LEVELS WERE RUNNING ABOVE 600 MG/DL. THE MOTHER CONFIRMED THE PRESENCE OF LARGE KETONES. THE PT'S SITE WAS CHANGED BEFORE THE ELEVATED BLOOD GLUCOSE LEVELS OCCURRED AND THE MOTHER NOTED NO ISSUES WITH THE INFUSION SITE. THE PT'S MOTHER CONFIRMED THAT ALL SETTINGS WERE CORRECT IN THE PUMP AND THE DELIVERY HISTORY MATCHED THE PUMP SETTINGS. THE PT'S DOCTOR PRESCRIBED INSULIN INJECTIONS AND THE PT'S MOTHER CONFIRMED THAT THE PT'S BLOOD GLUCOSE NORMALIZED AFTER USING INJECTIONS.

    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 5 YR Life Threatening| R