BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5029391 · Received August 25, 2015

    Report

    Report Number
    2531779-2015-29943
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/06/2015 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. UNRELATED TO THE CASING ISSUE, THE KEYPAD WAS FOUND TO BE TORN. ALL OF THE KEYPAD BUTTONS FUNCTIONED APPROPRIATELY. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 08/06/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562156 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR