BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3081767 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05436
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    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) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED ON THE PUMP AND HAD NO SIGNS OF DISCOLORATION OR FADING. UNRELATED TO THE DISPLAY ISSUE, THE PUMPS HISTORY SHOWED INCONGRUENT DAILY DOSE HISTORY AND A TIME AND DATE RESET TO FACTORY DEFAULT. THE BATTERY WAS REMOVED FROM THE PUMP DURING TESTING FOR SIX HOURS AND THEN REPLACED. WHEN THE PUMP POWERED ON, THE PUMP'S TIME AND DATE HAD RESET TO FACTORY DEFAULT. THE PUMP WAS OPENED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. 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 A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184555 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR