BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3233620 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11263
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/09/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/19/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED NO ACTIVITY OUTSIDE OF NORMAL USE. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE PROGRAMMED BASAL TARGET. THE PUMP POWERED ON AND DISPLAYED THE ¿VERIFY¿ SCREEN. THE PUMP SUCCESSFULLY PERFORMED THE ¿EZ-PRIME¿ STEPS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS EMITTED. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST. BOLUSES WERE PERFORMED CORRECTLY USING THE ¿NORMAL¿,¿EZ-CARB¿, ¿EZ-BG¿, AND ¿COMBO¿ BOLUS. ALL BOLUSES ACCURATELY RECORDED IN THE CORRECT TIME AND ORDER IN THE PUMP HISTORY. NO ISSUES WERE FOUND WITH THE KEYPAD 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THE PUMP WAS NOT RECORDING ALL OF THE BOLUSES. THE REPORTER STATED SHE WAS CERTAIN THAT THE PATIENT WAS PERFORMING ALL BOLUSES FROM THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334686 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR