BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3073390 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04929
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE (BG) HAD BEEN "HIGH" (>600MG/DL) FOR THREE DAYS AND THE PATIENT WAS TAKEN TO THE ER ON (B)(6) 2013. THE REPORTER NOTED THAT THE PATIENT HAS CHANGED OUT THE INFUSION SET AND BG COMES DOWN WITH BOLUS BUT THEN GOES UP AGAIN. THE PATIENT'S BG AT THE ER WAS REPORTEDLY 512MG/DL WITH KETONES AND NAUSEA. THE PATIENT WAS REPORTEDLY TREATED WITH BOLUSES VIA THE PUMP AND IV INSULIN DRIP FOR FLUIDS. THE PATIENT WAS TOLD IN THE ER THAT SHE MAY HAVE HAD A VIRUS. THE PATIENT REPORTEDLY REMAINS IN INSULIN PUMP THERAPY. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTED AND FOUND ALL SETTINGS AND HISTORIES ARE CORRECT; THERE WAS NO PUMP DEFECT FOUND DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE USING INSULIN PUMP THERAPY. IT IS UNCLEAR AT THIS TIME OF A POSSIBLE VIRUS WAS THE SOLE CAUSE OF THE REPORTED BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174826 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R