BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3000054 · Received March 12, 2013

    Report

    Report Number
    2531779-2013-02622
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    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 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS HAVE BEEN ERRATIC. THE REPORTER STATED THAT HIS BLOOD GLUCOSE LAST EVENING WAS 38MG/DL AND THE PARAMEDICS ASSISTED THE PATIENT WITH GLUCOSE VIA IV. THE PATIENT STATED TO THE REPORTER THAT HIS BG HAS BEEN HIGH AS 276MG/DL WITH TRACE KETONES. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE REPORTER STATED THAT SHE IS NOT NEAR THE PUMP WAS THE PATIENT IS AWAY AT COLLEGE. THE REPORTER STATED THAT HE HAD A LOT ON HIS PLATE. THE REPORTER STATED THAT THE PATIENT IS A SWIMMER AND WEARS THE INFUSION SET IN HIS THIGH. THE REPORTER STATED THAT THE PATIENT IS A SWIMMER AND HAS A LOT OF STRESS. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPOGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104215 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening