BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3854922 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16103
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY CAP THREADS WERE DAMAGED AND THE BATTERY CAP WAS NOT ABLE TO SECURE TIGHTLY TO THE PUMP. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION OBSERVED ON UNDERSIDE OF THE BATTERY CAP. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY CAP THREADS WERE DAMAGED AND THE BATTERY CAP WAS NOT ABLE TO SECURE TIGHTLY TO THE PUMP. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE UNDERSIDE OF THE BATTERY CAP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336060 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR