BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2992985 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02483
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 10, 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 PUMP HAD NO POWER AFTER THE PATIENT WENT INTO A HOT TUB WITH THE PUMP AND THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY. THE REPORTER MENTIONED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS READING HIGH ON THE METER WITHOUT SYMPTOMS. THE REPORTER STATED THEY WILL CONTACT THE HEALTHCARE PROFESSIONAL FOR INSTRUCTION ON TREATING HIGH BG AND USING ALTERNATIVE FORM OF INSULIN DELIVERY. THE PATIENT STATED THAT THE PUMP LAST REBOOTED ONE HOUR PRIOR TO CALL TO CUSTOMER SUPPORT. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98238 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening