BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3537487 · Received December 26, 2013

    Report

    Report Number
    2531779-2013-25259
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Report Date
    December 12, 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 12/12/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. IT WAS OBSERVED THAT THE TOP OF THE BATTERY CAP WAS DAMAGED, BUT DID SECURE PROPERLY TO A TEST PUMP DURING THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. THE BATTERY CAP WAS FOUND TO BE DAMAGED ON THE TOP OF THE CAP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/12/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676553 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR