BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1954330 · Received December 13, 2010

    Report

    Report Number
    2531779-2010-02858
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 14, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOW BATTERY WARNING APPEARED ONLY 1 WEEK AFTER REPLACING THE BATTERY, AND THE PUMP BECAME WARM TO TOUCH. THE PATIENT INDICATED THAT THE PUMP IS WORN IN THE SHOWER. THE PATIENT DENIED ANY CRACKS OR DAMAGE TO THE BATTERY COMPARTMENT, THE BATTERY CAP IS INTACT, AND THE BATTERY CAP IS SCREWED ON SECURELY. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1