BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100377 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26707
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP POWERS WITH RETURNED BATTERY CAP. THE KEYPAD IS UNRESPONSIVE TO USER INPUTS AT POWER UP. THE AUDIO BOLUS BUTTON COVER MISSING. INVESTIGATION SHOWS INTERNAL MOISTURE CONTAMINATION INSIDE AUDIO BOLUS BUTTON SWITCH CONTACT CAUSING BOLUS BUTTON TO BE SHORTED. THE KEYPAD WAS UNRESPONSIVE DUE TO SHORTED BOLUS BUTTON. REMOVED PUMP CASE AND THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION INSIDE PUMP. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER KEYPAD. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/05/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579719 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR