BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3926574 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19554
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: DURING TESTING, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED. ADDITIONALLY, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED EXTENDING FROM THE BATTERY CAP TOWARDS THE CASE SEAL. THE KEYPAD COVER WAS FOUND TO BE TORN AROUND THE UP ARROW BUTTON. DURING TESTING, THE CONTRAST BUTTON WAS FOUND TO BE UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP ARROW AND CONTRAST BUTTON CONTACTS. 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 FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. INVESTIGATION ALSO REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. ADDITIONALLY, CONTAMINATION WAS FOUND UNDER THE UP ARROW AND CONTRAST BUTTON CONTACTS. 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
    403625 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR