BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3920011 · Received July 8, 2014

    Report

    Report Number
    2531779-2014-19348
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP KEYPAD WAS OBSERVED TO BE PEELING AT THE OK BUTTON; THE KEYPAD RESPONSE WAS TESTED AND FOUND THAT THE CONTRAST BUTTON WAS INTERMITTENTLY RESPONDING BUT ALL OTHER BUTTONS RESPONDED APPROPRIATELY. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT CONTAMINATION WAS PRESENT UNDER THE KEYPAD BUTTON CONTACTS. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397033 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR