BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3608341 · Received February 5, 2014

    Report

    Report Number
    2531779-2014-03690
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/24/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AT THE OPENING OF THE BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE PUMP¿S BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/24/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74094 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR