BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242517 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11700
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 REPORTING THAT THE PATIENT WAS RUNNING ELEVATED BLOOD GLUCOSE LEVELS IN THE 300 MG/DL RANGE WITH NO SYMPTOMS. THE REPORTER INDICATED THAT THEY BELIEVED THE PUMP MAY NOT HAVE BEEN FUNCTIONING CORRECTLY RELATED TO THE ELEVATED BLOOD GLUCOSE LEVELS. THE REPORTER INDICATED THAT THE PUMP WAS NOT AVAILABLE FOR REVIEW AT THE TIME OF THE CALL. ANIMAS ATTEMPTED TO FOLLOW UP WITH THE REPORTER BUT HAS BEEN UNSUCCESSFUL AT THIS TIME. THE REPORTED BLOOD GLUCOSE LEVELS DO NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF A POTENTIAL PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344269 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR