BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210986 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09751
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THAT THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. A TEST SCREEN WAS USED FOR INVESTIGATION AND FOUND TO FUNCTION PROPERLY. UNRELATED TO THE DISPLAY ISSUE, EVALUATION REVEALED THE BATTERY CAP HAD STRIPPED THREADS AND WAS SPINNING IN PLACE. A CRACK WAS OBSERVED IN THE BATTERY COMPARTMENT. ALSO UNRELATED TO THE DISPLAY, TESTING REVEALED THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP WAS OPENED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS 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, DISCOLORED DISPLAY SCREEN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/10/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311154 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR