BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120215 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27486
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 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: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS PEELING FORM THE BASE AND TORN BETWEEN THE UP ARROW AND CONTRAST BUTTON. DURING TESTING, THE UP ARROW KEYPAD BUTTON WAS FOUND TO BE UNRESPONSIVE. THE DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE OK KEYPAD BUTTON RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. EVALUATION ALSO REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. ADDITIONALLY, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. 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 PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE UP ARROW KEYPAD BUTTON WAS UNRESPONSIVE WHILE THE DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. INVESTIGATION ALSO REVEALED THAT THERE WAS CONTAMINATION UNDER ALL KEYPAD BUTTON CONTACTS. FURTHERMORE, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. ADDITIONALLY, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602152 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR