BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3971102 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21959
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 25, 2014
    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) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. ON INVESTIGATION, THE PUMP POWERED UP TO A DIM AND DISCOLORED DISPLAY SCREEN. ALL THE KEYPAD BUTTONS RESPONDED PROPERLY. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED BETWEEN THE GRIP PAD AND THE CASE SEAL. NO EVIDENCE OF MOISTURE CORROSION WAS OBSERVED INSIDE THE COMPARTMENT. UNRELATED TO THE DISPLAY AND CASING ISSUE THE BOLUS BUTTON COVER WAS DAMAGED WHILE THE BUTTON WAS FUNCTIONAL.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE DISPLAY WAS DIM/DISCOLORED AND THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447913 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1