BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3072961 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04912
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 THE PATIENT HAD ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE PUMP. THE REPORTER INDICATED REVIEWING THE PUMP WITH THE PATIENT'S DOCTOR AND COULD NOT FIND ANYTHING WRONG WITH THE PUMP. THE REPORTER INDICATED THAT THE PATIENT WAS DISCONNECTED FROM THE PUMP BECAUSE THEY FIGURED THAT THE ELEVATED BLOOD GLUCOSE ISSUE WAS RELATED TO THE PUMP GETTING OLD. THERE IS NO REPORTED ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF AN UNSPECIFIED PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175296 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR