BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2940397 · Received February 3, 2013

    Report

    Report Number
    2531779-2013-01457
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 BY LEAVING A MESSAGE ALLEGING THAT THE PUMP WAS NOT DELIVERING THE BASAL DOSE EVERY HOUR. NO FURTHER INFORMATION WAS PROVIDED. ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) MADE SEVERAL ATTEMPTS BY TELEPHONE AND BY LETTER TO CONTACT THE PATIENT TO FOLLOW UP ON THE COMPLAINT. THE PATIENT DID NOT RESPOND TO ACTS'S ATTEMPTS TO FOLLOW UP ON THE COMPLAINT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THE PUMP WAS NOT DELIVERING THE BASAL DOSE EVERY HOUR AS DESIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45748 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR