BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3012474 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02841
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE THE PATIENT CONTACTED ANIMAS WAS (B)(4) 2013 AS PREVIOUSLY REPORTED.

    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 STATING THAT THE PUMP IS NOT GETTING THE INSULIN WHERE IT NEEDS TO GO. THE REPORTER STATED THAT THE ENTIRE BOLUS IS BEING DELIVERED BUT THE BLOOD GLUCOSE LEVELS ARE RUNNING HIGH. THERE WERE NO REPORTED BLOOD GLUCOSE VALUES. THERE WAS NO ADDITIONAL INFORMATION AT THIS TIME. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116348 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR