BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840044 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13796
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS STATING THAT ON THE MORNING OF (B)(6) 2012, THE PUMP EMITTED SEVERAL OCCLUSION ALARMS AND THE PATIENT'S BLOOD GLUCOSE (BG) WAS READING "HIGH" ON THE METER. THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF VOMITING AND KETONES AND WAS HOSPITALIZED. THE PATIENT WAS REPORTEDLY TREATED VIA INTRAVENOUSLY (IV) FOR HYDRATION AND BY CORRECTION INJECTION. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE REPORTER AND THE PATIENT AND DETERMINED THERE WAS NO INDICATION OF A PUMP MALFUNCTION. THERE WERE NO SITE/SET OR CARTRIDGE ISSUES NOTED. CS ADVISED THE REPORTER AND THE PATIENT TO CONTACT THE HEALTH CARE PROVIDER (HCP) FOR ASSISTANCE WITH THE PROGRAMMING/SETTINGS ON THE PUMP AND TO CONTINUE MONITORING THE BG READINGS. THE PATIENT'S BG VALUES ARE REPORTEDLY STABLE; THE PATIENT RESUMED INSULIN PUMP THERAPY AND HAS A BACK-UP SYSTEM IF NEEDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED BG EXCURSION AS THE PATIENT WAS NOT RESPONDING TO ALARMS APPROPRIATELY.

    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 15 YR Hospitalization| L| R