BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2852816 · Received November 30, 2012

    Report

    Report Number
    2531779-2012-14109
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT THE METER INITIATED 14 0.00 BOLUSES. THE PATIENT STATED THAT THE METER WAS ZIPPED UP IN THE METER CASE AND THE CASE WAS IN HER PURSE. THE PATIENT MENTIONED THAT SHE BELIEVES THAT NOTHING WOULD HAVE PRESSED AGAINST THE BUTTONS. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING METER REMOTE

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR