BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181768 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05373
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/14/2011 WITH THE FOLLOWING FINDINGS: INVESTIGATION CONFIRMED THAT THE AUDIO BOLUS IS INTERMITTENTLY RESPONSIVE AND DIFFICULT TO PRESS. EVALUATION REVEALED THAT THE BOLUS BUTTON PLUG IS MISALIGNED. ALL OTHER KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO BUTTON PRESSES, AND THERE WERE NO OTHER KEYPAD DEFECTS FOUND ON INVESTIGATION. 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

    THE PATIENT REPORTED THAT THE AUDIO BOLUS BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST COUPLE OF WEEKS. HE STATED THAT HE WEARS THE PUMP IN A CASE ON HIS BELT, AND DENIED CLEANING THE PUMP.

    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