BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033033 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03481
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/06/2013 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED. THE OLD SCREEN WAS REMOVED AND REPLACED WITH A NEW SCREEN AND THE DISPLAY RETURNED TO NORMAL. UNRELATED TO THE DISPLAY ISSUE, THE AUDIO BOLUS BUTTON WAS FOUND TO BE INOPERABLE DUE TO A MISSING COVER AND MISSING SLUG. ALSO UNRELATED, THE KEYPAD WAS OBSERVED TO BE TORN AT THE OK BUTTON; THE OK BUTTON WAS FOUND TO BE RESPONDING INTERMITTENTLY AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACT. THE DAMAGE TO THE AUDIO BOLUS AND KEYPAD BUTTONS IS OBVIOUS AND DETECTABLE TO THE USER AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE DEVICE. ALSO UNRELATED, THE PUMP EMITTED A CALL SERVICE 078 ALARM WHICH WAS DUPLICATED DURING TESTING; THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE PUMP MOTOR ASSEMBLY. 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 TO ANIMAS AND WAS INVESTIGATED BY PRODUCT ANALYSIS. THE INVESTIGATION REVEALED A FADED AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136169 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR