BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1790057 · Received August 2, 2010

    Report

    Report Number
    2531779-2010-00843
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED AN EVALUATION AN EVALUATION WILL BE CONDUCTED, AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT HAS ONLY USED THE PUMP FOR ONE DAY BEFORE THE HOSPITALIZATION AND ASKED ANIMAS FOR ASSISTANCE ON PUMP SETTINGS CHANGES. AT THE TIME OF THE CONTACT, THE PATIENT WAS WORKING WITH A HEALTH CARE PROFESSIONAL ON RESUMING PUMP THERAPY. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization