BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2143249 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04538
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON THE INVESTIGATION RESULTS COMPLETED ON 05/20/2011. CORRECTION #: 2531779-03/24/2010-003-R. DURING EVALUATION, THE FORCE SENSOR FLEX CONNECTOR WAS FOUND TO BE TORN AT THE FORCE SENSOR PINS AND THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. THE FORCE SENSOR WAS FOUND TO HAVE A BAD CALIBRATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED AN INTERMITTENT FLEX CONNECTION AT THE FORCE SENSOR PINS AND A DAMAGED FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    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 46 YR