BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2921206 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00832
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND LEFT A MESSAGE STATING THE PUMP WAS NOT WORKING. THE PATIENT REPORTEDLY HAS BEEN EXPERIENCING BLOOD GLUCOSE (BG) VALUES OVER 400MG/DL. THERE WERE NO REPORTED SYMPTOMS. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. CUSTOMER SUPPORT (CS) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER AND HAS BEEN UNSUCCESSFUL. THE REPORTED BG IS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26755 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR