BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1872108 · Received October 8, 2010

    Report

    Report Number
    2531779-2010-01542
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. WHILE SPEAKING TO THE ANIMAS CDE, THE REPORTER DID NOT HAVE THE PUMP ON HAND FOR TROUBLESHOOTING. THE PT WAS ADVISED TO CALL ANIMAS BACK. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER (THE PT'S WIFE) ALLEGED THAT THE PUMP OVER DELIVERS INSULIN AND CAUSES HER HUSBAND'S BLOOD GLUCOSE LEVELS TO DROP IN THE 30'S.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening