BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3780801 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11895
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 05/22/2014. ADDITIONAL INFORMATIONTHIS FOLLOW UP REPORT IS BEING SUBMITTED TO INCLUDE ADDITIONAL INFORMATION NOT PROVIDED ON THE FIRST FOLLOW UP: 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

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: WHEN THE PUMP WAS POWERED ON, THE DISPLAY SCREEN WAS BLANK. THE PUMP DID HAVE AUDIBLE TONES AND NORMAL VIBRATORY FUNCTIONS. THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. THE BROKEN DISPLAY SCREEN WAS REMOVED AND REPLACED IT WITH A TEST SCREEN. THE TEST SCREEN WORKED WITH NO ISSUES FOUND. THE ALLEGATION OF A DIM AND FADING DISPLAY SCREEN COULD NOT BE DUPLICATED DURING INVESTIGATION AS A RESULT OF THE DAMAGED DISPLAY SCREEN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN HAD BECOME DIM AND FADED. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260268 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1