BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3882479 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17507
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE KEYPAD WAS INTACT WITHOUT DAMAGE. ON TESTING, ALL THE KEYPAD BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE BUTTON CONTACTS. INVESTIGATION DID NOT CONFIRM OR DUPLICATE THE ALLEGED MALFUNCTION AND THE PUMP WAS FOUND TO BE PERFORMING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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).

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE UP ARROW AND DOWN ARROW BUTTONS WERE UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD BUTTON ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357565 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1