BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3780904 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11790
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 10/16/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/01/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP BLACK BOX DATA REVEALED THAT INFORMATION FROM THE EVENT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED USE. THE AVAILABLE HISTORY SHOWED NO ERRORS, ALARMS, OR WARNINGS RELATED TO THE COMPLAINT. DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED THE EZ PRIME STEPS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIME WARNINGS. THE COMPLAINT WAS NOT DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS MISSING. 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)(4)

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PUMP MAKES A VERY LOUD NOISE AND VIBRATES EVERY FOUR MINUTES; HOWEVER, THERE IS NO ALARM CODE ON THE DISPLAY SCREEN. CHANGING THE BATTERY DOES NOT RESOLVE THE ISSUE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260626 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1