BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3811549 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13568
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/20/2014. 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 06/30/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE BATTERY COMPARTMENT AND BATTERY CAP WERE NOTED TO BE INTACT WITHOUT DAMAGE. THE BATTERY CAP WAS ABLE TO MAINTAIN ELECTRICAL CONNECTION WHEN SECURED ON THE PUMP. WHEN ATTEMPTING TO POWER ON THE PUMP, THE PUMP EMITTED AUDITORY ALERTS; HOWEVER, THE DISPLAY SCREEN REMAINED BLANK. THE PUMP DID NOT EMIT VIBRATORY ALERT. THE BLACK BOX DATA AND DOWNLOAD HISTORY WAS UNABLE TO BE DOWNLOADED DURING INVESTIGATION. ON EXAMINATION, THE DISPLAY SCREEN WAS INTACT WITHOUT DAMAGE. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE CORROSION PRESENT ON THE POWER CIRCUIT AND THE PRINTED CIRCUIT BOARD AND ITS COMPONENTS.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. 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
    291852 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1