BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3760389 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10576
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 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 AT THE TIME OF THIS REPORT. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/05/2014 WITH THE FOLLOWING FINDINGS: THE DOWN AND OK BUTTONS HAD AN INTERMITTENT RESPONSE. CONTAMINATION WAS FOUND UNDERNEATH THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE KEYPAD ISSUE, THE AUDIO BOLUS BUTTON WAS FOUND TO BE TORN, BUT STILL NORMALLY RESPONSIVE. ADDITIONALLY, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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) 2014, A DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241189 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1