BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6258168 · Received January 17, 2017

    Report

    Report Number
    2531779-2017-01353
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Report Date
    December 25, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 03/114/2017. 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 02/21/2017 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE KEYPAD COVER WAS INTACT AND WITHOUT DAMAGE. ON INVESTIGATION, ALL THE KEYPAD BUTTONS HAD NORMAL RESPONSE WHEN TESTED. 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 DUPLICATE THE COMPLAINT. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION REVEALING A TEAR IN THE KEYPAD FLEX (WIRE).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41854 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1