BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3935533 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20117
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/07/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE TORN BETWEEN THE UP ARROW BUTTON AND THE DOWN ARROW BUTTON. DURING TESTING, THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THE UP ARROW AND CONTRAST BUTTON CONTACTS WERE FOUND TO BE MISSING. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE DOWN ARROW AND OK BUTTON CONTACTS. ADDITIONALLY, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BETWEEN THE CASE SEAL AND GRIP PAD. FURTHERMORE, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE UP ARROW KEYPAD BUTTON WAS UNRESPONSIVE. INVESTIGATION ALSO REVEALED THAT THE UP ARROW BUTTON CONTACT WAS MISSING AND THERE WAS CONTAMINATION UNDER THE DOWN AND OK BUTTON CONTACTS. ADDITIONALLY, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND 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 07/07/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412638 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR