BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161480 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08044
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS METER 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. TROUBLESHOOTING OF THE EVENT INDICATED THAT THE PUMP AND METER REMOTE WERE NOT PAIRED RESULTING IN LACK OF COMMUNICATION BETWEEN DEVICES. THE PUMP CAN STILL BE MANIPULATED WITHOUT PAIRING THE PUMP WITH A METER REMOTE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING JUST RECEIVING A NEW PUMP BUT DID NOT PAIR THE PUMP TO THE METER REMOTE. THE REPORTER INDICATED THAT THE PUMP AND METER WERE NOT COMMUNICATING TO DELIVER BOLUSES RESULTING IN A BLOOD GLUCOSE OF 300 MG/DL WITH STOMACH PAIN. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO USE OF AN UNPAIRED METER REMOTE AND PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263214 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening