BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183166 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05426
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 515 MG/DL AND SUFFERED THE SYMPTOMS OF NAUSEA, VOMITING AND ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED INTRAVENOUSLY WITH INSULIN. WHEN THE PUMP WAS REMOVED IN THE HOSPITAL, THE CANNULA WAS FOUND BENT AT THE INFUSION SITE. DURING THE TROUBLESHOOTING TELEPHONE CALL, IT WAS DETERMINED THE PUMP DATE/TIME WERE CORRECT, THE BASAL SETTING WAS CORRECT AND TOTALS DELIVERED CORRECTLY MATCHED THOSE PROGRAMMED, AND ALL PUMP SETTINGS WERE CORRECT. THE PUMP HISTORY REVEALED OCCLUSION ALARMS AND CANCELED BOLUSES. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. THE PATIENT'S TECHNIQUE WAS INCORRECT IN THAT THE CANNULA WAS BENT. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AND WAS ADMITTED TO THE HOSPITAL WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L