BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2031449 · Received March 17, 2011

    Report

    Report Number
    2531779-2011-01773
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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

    THE PATIENT CLAIMED THAT HER PUMP HAS POWERED OFF ON ITS OWN 4 TIMES IN THE LAST 2-3 DAYS. THE PATIENT STATED THAT THE BATTERY CAP WAS INTACT AND SECURELY ATTACHED TO THE PUMP. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE AND DOES NOT HAVE ANY PHYSICAL DAMAGE OR CORROSION. 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 CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1