BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4948375 · Received July 28, 2015

    Report

    Report Number
    2531779-2015-25883
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/13/2015 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED BATTERY COMPARTMENT CRACKS OBSERVED IN THREAD AREA AND BELOW GRIP PAD. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/13/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490647 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR