BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3873711 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17056
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/17/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE ALLEGED DISPLAY ISSUE WAS DUPLICATED. THE PUMP POWERED UP TO A DIM DISPLAY WITH PINKISH CONTRAST. THE AUDITORY AND VIBRATORY FEATURES WERE OPERATIONAL. NO TACTILE ISSUES WERE FOUND WITH THE BUTTONS. UNRELATED TO THE DISPLAY ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED BELOW THE GRIP PAD AT THE CASE SEAL.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THAT THE DISPLAY IS DIM/FADED/ DISCOLORED. THERE WAS NO REPORTED IMPACT TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED DISPLAY ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352191 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR