BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3475270 · Received November 18, 2013

    Report

    Report Number
    2531779-2013-21233
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Report Date
    November 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: CONFIRMED THE BATTERY COMPARTMENT IS CRACKED AT OPENING OF BATTERY CHAMBER EXTENDING DOWN BEHIND THE FINGERPAD. A TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. NO LOSS OF POWER, NO EVIDENCE OF MOISTURE DAMAGE IN BATTERY COMPARTMENT. TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'DOWN' AND 'CONTRAST' BUTTONS. MULTIPLE BUTTON PRESSES WITH INCREASED FORCE APPLIED ARE REQUIRED BEFORE THE 'DOWN' AND 'CONTRAST' BUTTONS ENGAGE. NO VISIBLE DAMAGE ON THE KEYPAD. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. 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

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, UNRESPONSIVE KEYS, AND CONTAMINATION UNDER THE KEYPAD CONTACTS. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597514 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1