BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2102981 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03697
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION # = 2531779-03/24/2010/003-R. ON (B)(4), 2011 EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME ALARMS ASSOCIATED WITH LOW FORCE. REWIND, LOAD AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. THE PUMP WAS EXERCISED WITH NO ALARMS OCCURRING.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR