BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3550373 · Received January 3, 2014

    Report

    Report Number
    2531779-2014-00239
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Report Date
    December 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/19/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP WAS NOT ABLE TO POWER ON DUE TO MOISTURE CORROSION IN THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE THREADS. A PUMP LEAK WAS FOUND DURING TESTING. FURTHER TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE UNRESPONSIVE PUMP. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE PUMP WAS NOT FUNCTIONING DUE TO MOISTURE CORROSION IN THE BATTERY COMPARTMENT. EVALUATION REVEALED A CRACK AT THE BATTERY COMPARTMENT THREADS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/19/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4358 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR