BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3232107 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11105
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH FUNCTIONAL AUDITORY AND VIBRATORY FEATURES, BUT THE DISPLAY SCREEN WAS BLANK. THE PUMP CASING WAS OPENED AND DAMAGE TO THE DISPLAY CONNECTOR WAS NOTED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY; THE TEST DISPLAY WAS NOT FUNCTIONAL IN THE PUMP. UNRELATED TO THE DISPLAY ISSUE, VISUAL INSPECTION REVEALED MOISTURE IN THE BATTERY COMPARTMENT AND CORROSION ON THE BATTERY CAP. A BATTERY COMPARTMENT CRACK WAS OBSERVED. 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 A BLANK DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330640 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1