BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2901963 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00370
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 INDICATING THAT THE PUMP LOST POWER WHILE THE PATIENT WAS SLEEPING AND THE PATIENT'S BLOOD GLUCOSE ROSE TO 400MG/DL WITH SYMPTOMS OF VOMITING. THE PUMP REPORTEDLY HAS A CRACK NEAR THE BATTERY COMPARTMENT AND THE YELLOW O-RING IS VISIBLE. THE PATIENT REPORTEDLY SOMETIMES WILL USE THEIR TEETH TO REMOVE THE CAP FROM THE PUMP. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS RELATED POWER LOSS RELATED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9977 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening