BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS VIBE

    MDR report key: 3760318 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10587
    Date Received
    April 21, 2014
    Report Date
    March 31, 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

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 #1: DATE OF SUBMISSION 06/16/2014. 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 06/10/2014 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE PUMP POWERED ON NORMALLY; HOWEVER, THE DISPLAY SCREEN WAS NOTED TO BE DAMAGED, CONSISTENT WITH AN IMPACT. NO POWER INTERRUPTION OR LOSS OCCURRED DURING INVESTIGATION. THE PUMP WAS OPENED FOR INVESTIGATION REVEALING FURTHER EVIDENCE OF MULTIPLE CRACKS IN THE DISPLAY SCREEN. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND WAS FULLY ILLUMINATED AND LEGIBLE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PUMP HAD NO POWER; THE DISPLAY SCREEN WAS REPORTEDLY BLANK AND NO AUDIO TONES OR VIBRATORY FUNCTION. THE REPORTER DENIED ANY DAMAGE TO THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239219 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR