BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3760391 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10578
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 25, 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 #1 06/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 06/04/2014 WITH THE FOLLOWING FINDINGS: THE ALLEGATION OF AN UNRESPONSIVE OK BUTTON COULD NOT BE DUPLICATED. ALL OF THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE AND FUNCTIONAL. NO CONTAMINATION OR ANY OTHER ANOMALY WAS FOUND ON THE DEVICE¿S KEYPAD. 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 DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE OK BUTTON WAS UNRESPONSIVE. 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
    240864 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1