BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983705 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22572
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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) 2014, A REPORTER CONTACTED ANIMAS ALLEGING A PUMP WAS INACCURATELY DELIVERING INSULIN TO A PATIENT. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE LEVEL OF 350 MG/DL WITH EXCESS URINATION. THE REPORTER STATED THAT THE PATIENT REMAINED ON THE PUMP AFTER THE INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE TROUBLESHOOTING WITH A CUSTOMER TECHNICAL SUPPORT REPRESENTATIVE COULD NOT BE COMPLETED AND THE ISSUE REMAINED UNRESOLVED. THE ALLEGED BLOOD GLUCOSE LEVEL AND SYMPTOMS DO NOT MEET THE REQUIREMENTS TO BE A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460403 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR