BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4052669 · Received September 2, 2014

    Report

    Report Number
    2531779-2014-24934
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Report Date
    August 12, 2014
    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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH NO AUDIBLE TONES PRESENT. THE PUMP WAS OPENED AND THE AUDIBLE TONE CIRCUIT CONTACTS WERE OUT OF ALIGNMENT. THE CONTACTS WERE REALIGNED AND THE PUMP WAS FOUND TO BOOT WITH FUNCTIONAL AUDIO TONES. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE PUMP AUDIBLE TONE WAS NOT WORKING. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534797 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR