BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4188539 · Received October 21, 2014

    Report

    Report Number
    2531779-2014-29758
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY LENS IS SCRATCHED IN MULTIPLE AREAS. 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. EVALUATION REVEALED THE DISPLAY WAS SCRATCHED IN MULTIPLE PLACES. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/23/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667343 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR