BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2142436 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04529
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 05/31/2011. RECALL 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND THE FORCE SENSOR FLEX CONNECTOR WAS FOUND TO BE PARTIALLY TORN. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PUMP WAS OPERATING WITHIN SPECIFICATIONS AT THE TIME OF RELEASE.

    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 OUT OF CALIBRATION FORCE SENSOR. 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 12 YR