BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4430213 · Received January 19, 2015

    Report

    Report Number
    2531779-2015-01887
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Report Date
    December 31, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2: DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/12/2015 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE ALLEGED BUTTON TACTILE ISSUE WAS NOT DUPLICATED. THE PUMP POWERED UP TO THE DISPLAY WITH AUDITORY AND VIBRATORY FEATURES. THE KEYPAD COVER WAS INTACT AND ALL THE BUTTONS RESPONDED PROPERLY. REMOVAL OF THE COVER DID NOT FIND ANY CONTAMINATION UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FOUND TO BE DIM WITH A REDDISH CONTRAST AND THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED IN THE THREADS AREA.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - SUBMISSION DATE 05/08/2015; 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. CORRECTIONS TO THE INITIAL REPORT ARE AS FOLLOW: THE CORRECT BRAND NAME IS ANIMAS VIBE. THE CORRECT MODEL# IS ANIMAS VIBE INSULIN PUMP; THE CORRECT SERIAL# IS (B)(4). THE CORRECT PMA/510(K) # IS P130007. THE CORRECT DEVICE MANUFACTURING DATE IS 02/27/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. REPORTEDLY THE ¿OK¿, ¿UP¿ AND ¿DOWN¿ BUTTONS WERE UNDER RESPONSIVE. IT WAS REPORTED THAT THE KEYPAD COVER WAS INTACT, THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP AND THERE WAS NO DELIVERY ISSUES NOTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42942 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR