BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3181537 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08714
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/30/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE BLANK WHEN THE PUMP WAS POWERED ON. THE PUMP¿S AUDIBLE AND VIBRATORY ALARMS WERE FUNCTIONAL. THE PUMP WAS OPENED AND EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS CRACKED. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE DISPLAY HAS BLANK SCREEN. THERE WAS NO EVIDENCE OF MOISTURE BUT DID SWIM YESTERDAY. THE REPORTER DENIED DAMAGE TO THE PUMP. THE REPORTER CONFIRMED THAT THE AUDIBLE TONES STILL WORK. THE BATTERY WAS CHANGED BUT IT DID NOT MAKE ANY DIFFERENCE IN DISPLAY. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283564 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR