BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2123569 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04146
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(4) 2011AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE OF HI ON THE METER (OVER 600 MG/DL) WITHOUT ANY SYMPTOMS. THE FAMILY MEMBER REPORTED THAT THE PATIENT WOKE UP TO FIND THE PUMP WAS SUSPENDED. THE FAMILY MEMBER STATED THAT SHE THOUGHT THE PATIENT ACCIDENTALLY SUSPENDED THE PUMP AS THIS COULD HAVE HAPPENED BY THE WAY THE PATIENT WEARS THE PUMP IN POCKET WHEN SLEEPING. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD IS INTACT AND ALL BUTTONS ARE RESPONDING APPROPRIATELY. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER TO LOCK THE PUMP WHEN THE PATIENT WEARS THE PUMP IN POCKET. THIS REPORT WAS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER THE PUMP SUSPENDED WITHOUT USER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention