BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2820883 · Received November 6, 2012

    Report

    Report Number
    2531779-2012-13216
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD RUBBER WAS INTACT. EVALUATION REVEALED THAT THE CONTRAST, DOWN AND UP BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE OK BUTTON RESPONDED APPROPRIATELY. THERE WAS CONTAMINATION PRESENT UNDER ALL THE KEY CONTACTS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE CONTRAST, UP AND DOWN BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION UNDER ALL OF THE KEYS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2012.

    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 52 YR