BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072270 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02978
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    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 FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE BLACK BOX DATA BEGINS ON 08/19/2013. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE OF (B)(6) 2011 AND ALL HISTORIES AND BLACK BOX DATA FOR THE EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE HISTORY CONTAINS ONLY TYPICAL USAGE ALARMS; NOTHING RELATED TO THE COMPLAINT WAS RECORDED. THE TOTAL DAILY DOSE AMOUNTS ADD UP APPROPRIATELY SHOWING THE PUMP WAS DELIVERING ACCURATELY. THE PUMP SUCCESSFULLY PASSED A 29 HOUR FLOW ACCURACY TEST. NO ALARMS OCCURRED DURING TESTING. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S GRANDFATHER, REPORTED THAT ON (B)(6) 2011, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 511 MG/DL, AND SHE WAS EXPERIENCING THE SYMPTOM OF VOMITING. THE PATIENT DID NOT TEST FOR URINARY KETONES. TROUBLESHOOTING REVEALED THERE WERE NO KINKS, BENDS OR LEAKS IN THE TUBING, ALL BASAL/BOLUS TOTAL DOSES CORRECTLY AND ACCURATELY MATCH THOSE PROGRAMMED, ALL PUMP SETTINGS WERE CORRECT, AND THE PUMP DATE/TIME WERE CORRECT. THE REPORTER ALSO NOTED HE HAD NOTICED THE PATIENT PRESSING THE BUTTON AND CANCELLING A BOLUS BEFORE THE BOLUS DOSE WAS COMPLETELY DELIVERED. THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING A BOLUS DOSE AND HER BLOOD GLUCOSE LEVEL DROPPED TO 379 MG/DL. THE PATIENT'S TECHNIQUE WAS INCORRECT IN PRESSING THE BUTTON BEFORE THE BOLUS DOSE WAS COMPLETELY DELIVERED. THERE IS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN AS PROGRAMMED. HOWEVER, AS THE PATIENT EXPERIENCED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA 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 11 YR Life Threatening| R