BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3073237 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04920
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. EVALUATION WAS COMPLETED WITH A TEST DISPLAY SCREEN, THE CONTRAST RETURNED TO NORMAL WITH TEST SCREEN. THE DISPLAY SCREEN WAS FOUND TO BE SCRATCHED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE CRACKED BATTERY COMPARTMENT. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD WAS WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY (B)(6) DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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 DISPLAY SCREEN WAS DIM AND SCRATCHED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/28/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174544 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR