BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1941802 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03018
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, (B)(6) 2010, AND (B)(6) 2010 WITH DKA. THE ANIMAS CDE REPORTED THAT THE HOSPITAL STAFF EXAMINED THE INFUSION SET ON (B)(6) 2010 AND SAID THAT IT WAS BENT UPON REMOVAL. THERE IS INDICATION THAT THE PT AND HIS FAMILY WILL RECEIVE ADDITIONAL TRAINING ON INSULIN PUMP THERAPY. DUE TO THE PAUCITY OF EVIDENCE, THIS COMPLAINT IS REPORTED FOR PROBABLE USE ERRORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization