BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2944330 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01486
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT'S LACK OF KNOWLEDGE ON THE FUNCTIONALITY OF THE PUMP).

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH DIABETIC KETOACIDOSIS AND A BLOOD GLUCOSE (BG) OF 850MG/DL. THE PATIENT REPORTED THAT SHE WAS NOT ON THE PUMP AT THE TIME OF THIS EVENT. THE PATIENT IS ON INJECTIONS PER HER HEALTHCARE PROFESSIONAL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE PATIENT FOR THIS INCIDENT. THE PUMP IS NOT BEING RETURNED. THERE WAS NO MALFUNCTION FOUND WITH THE PUMP. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM THE PATIENT'S LACK OF KNOWLEDGE ON THE FUNCTIONALITY OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48325 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization