BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2854989 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14188
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING SEQUENCE OF EVENTS: UPON WAKING THIS MORNING, THE PUMP WAS ALARMING FOR LOSS OF PRIME/OCCLUSION AND THE CHILD WAS VOMITING. THE MOTHER DROVE TO THE EMERGENCY ROOM, AND THE CHILD WAS BEING ADMITTED TO THE INTENSIVE CARE UNIT WITH HYPERGLYCEMIA. NO OTHER INFORMATION IS PROVIDED. THIS COMPLAINT IS BEING REPORTED AS A PATIENT ON AN INSULIN PUMP EXPERIENCED HYPERGLYCEMIA REQUIRING HOSPITALIZATION.

    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 16 YR Hospitalization