BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6036272 · Received October 18, 2016

    Report

    Report Number
    2531779-2016-28901
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100068
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/08/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, ALL THE KEYPAD BUTTONS RESPONDED APPROPRIATELY TO USER INPUT. THE ORIGINAL COMPLAINT OF AN UNDER RESPONSIVE OK KEYPAD BUTTON WAS UNABLE TO BE DUPLICATED. NO PHYSICAL DAMAGE WAS FOUND TO THE KEYPAD. THE KEYPAD WAS REMOVED TO FIND NO CONTAMINATION OR PHYSICAL DAMAGE. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED AT THE CASE SEAL TO THE LEFT OF THE BUMPER PAD.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THE OK BUTTON WAS UNDER RESPONSIVE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE 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
    689151 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100068

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR