BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2030687 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01791
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND FULLY DISLODGED FORCE SENSOR PINS, OUT OF CALIBRATION FORCE SENSOR, LEAD SCREW CONTAMINATION AND CONTAMINATION ON THE FORCE SENSOR. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    PT REPORTS PUMP DISPENSED INSULIN DURING LOAD CARTRIDGE PHASE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1