BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133049 · Received June 18, 2011

    Report

    Report Number
    2531779-2011-04261
    Event Type
    Injury
    Date Received
    June 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PATIENT'S BLOOD GLUCOSE HAS BEEN INCREASED AS HIGH AS 500 MG/DL OVER THE PAST (B)(6). THE PUMP SETTINGS HAVE BEEN ADJUSTED BUT THE HIGH BLOOD GLUCOSE RESULTS HAVE PERSISTED. THERE IS EVIDENCE OF A POSSIBLE TECHNIQUE ISSUE AS THE INSULIN SITE OF DISPENSE HAS BEEN CHANGED 5 TIMES IN THE (B)(6). DURING THE SITE CHANGE, ONE BENT CANNULA WAS IDENTIFIED WITH INSULIN LEAKAGE DUE TO CANNULA NOT PROPERLY INSERTED. THE ANIMAS REPRESENTATIVE WITH THE PATIENT'S FATHER AND HAVE CAME TO A CONCLUSION. THE FATHER ACKNOWLEDGED THAT WHEN THE SITE WAS CHANGED, THE CANNULA WAS CLEARLY BENT. THE FATHER FURTHER STATED DOES NOT FEEL THE HIGH BLOOD GLUCOSE IS NOT RELATED TO THE PUMP BUT RATHER A SITE ISSUE POSSIBLE RELATED TO IMPROPER INSERTION TECHNIQUE. THE ANIMAS REPRESENTATIVE WENT OVER THE PROPER TECHNIQUE TO MINIMIZE ANY POTENTIAL FOR BENT CANNULAS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY HAD HYPERGLYCEMIA POSSIBLY DUE TO A USER ERROR AND IMPROPER CANNULA INSERTION TECHNIQUE.

    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 6 YR Life Threatening