BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4862004 · Received June 23, 2015

    Report

    Report Number
    2531779-2015-20720
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 6, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2015 WITH THE FOLLOWING FINDINGS: A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE BATTERY COMPARTMENT THREADS WERE DAMAGED. THE KEYPAD WAS MISSING. 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 BATTERY COMPARTMENT CRACK AND DAMAGED BATTERY COMPARTMENT THREADS. THE KEYPAD COVER WAS MISSING. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 06/06/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407239 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR