BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3580391 · Received January 17, 2014

    Report

    Report Number
    2531779-2014-01809
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/23/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED, EXTENDING FROM THREADS DOWN TO THE SEAL. THE PUMP FAILED A LEAK TEST DUE A BATTERY COMPARTMENT LEAK. THE PUMP¿S COVER WAS REMOVED AND MOISTURE CORROSION WAS FOUND TO THE PRINTED CIRCUIT BOARD AND OTHER INTERNAL COMPONENTS. 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)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THE PUMP FAILED A LEAK TEST DUE A BATTERY COMPARTMENT LEAK AND MOISTURE CORROSION WAS FOUND ON THE PRINTED CIRCUIT BOARD AND OTHER INTERNAL COMPONENTS OF THE PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/23/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45480 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR