BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3501035 · Received December 5, 2013

    Report

    Report Number
    2531779-2013-23080
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT IS CRACKED EXTENDING FROM THREADS DOWN TO THE FINGER PAD, THE BATTERY CAP IS UNDAMAGED AND ABLE TO FIT SECURELY. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/25/2013

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631440 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR