BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANGEMENT SYSTEM

    MDR report key: 1861966 · Received October 5, 2010

    Report

    Report Number
    2531779-2010-01441
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 4, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS HOSPITALIZED DUE A BONE INFECTION, THE PATIENT SUBSEQUENTLY EXPERIENCED KIDNEY FAILURE AND CONGESTIVE HEART FAILURE. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED DUE A BONE INFECTION, THE PATIENT SUBSEQUENTLY EXPERIENCED KIDNEY FAILURE AND CONGESTIVE HEART FAILURE. WHILE IN THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE LEVEL ELEVATED TO 700 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R