BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1812860 · Received August 13, 2010

    Report

    Report Number
    2531779-2010-00924
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    June 19, 2010
    Report Date
    June 19, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. REVIEW OF THE PUMP HISTORY REVEALS SEVERAL LOSS OF PRIME ALARMS ASSOCIATED WITH ZERO FORCE. THE PUMP WAS PRIMED SUCCESSFULLY AND EXERCISED WITH NO LOSS OF PRIME ALARMS DUPLICATED.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    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 21 YR