BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1881627 · Received October 20, 2010

    Report

    Report Number
    2531779-2010-01743
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. A REVIEW OF PUMP HISTORY INDICATED THAT MULTIPLE LOW (NON-ZERO) FORCE LOSS OF PRIME WARNINGS HAD OCCURRED. THE PUMP WAS EXERCISED AND LOST PRIME WITHIN A 24-HOUR PERIOD. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE OUT OF CALIBRATION. EVALUATION ALSO REVEALED A DISLODGED DISPLAY SCREEN.

    Description of Event or Problem · 1

    THE PATIENT REPORTED MULTIPLE LOSS OF PRIME WARNINGS FOR THE PAST SEVERAL MONTHS. IT WAS REPORTED THAT THE FREQUENCY INCREASED RECENTLY AND RESULTED IN 5 LOSS OF PRIME WARNINGS IN ONE MORNING. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. EVALUATION ALSO REVEALED A DISLODGED DISPLAY.

    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 41 YR