BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1870246 · Received October 1, 2010

    Report

    Report Number
    2531779-2010-01418
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING EVAL THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THE DISPLAY SCREEN WAS FOUND TO BE DISLODGED.

    Description of Event or Problem · 1

    DURING EVAL THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR