BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3951972 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21054
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 3, 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/11/2014 WITH THE FOLLOWING FINDINGS: MOISTURE CORROSION WAS OBSERVED ON THE DISPLAY SCREEN INSIDE THE PUMP. THE PUMP FAILED A LEAK TEST DUE A DISPLAY LENS LEAK. THE KEYPAD RUBBER WAS UNDAMAGED. THE PUMP ALARMED WITH A HARD CALL SERVICE ALARM. THE RESPONSIVENESS OF THE KEYPADS COULD NOT BE INVESTIGATED AS A RESULT OF THE CALL SERVICE ALARM. THE KEYPAD WAS REMOVED AND NO CONTAMINATION OR DAMAGE WAS FOUND TO THE KEY¿S CONTACTS. MOISTURE CORROSION WAS FOUND TO THE PRINTED CIRCUIT BOARD ON THE DISPLAY SCREEN, THE KEYPAD FLEX/CONNECTOR, THE CONTINUOUS GLUCOSE MONITOR MODULE, AND OTHER INTERNAL COMPONENTS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE DOWN, UP, AND OK BUTTONS WERE UNRESPONSIVE. THE REPORTER ADDITIONALLY ALLEGED THAT THERE WAS MOISTURE IN THE PUMP BEHIND THE DISPLAY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF A SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431012 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR