BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3844377 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15477
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 16, 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 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).

    Additional Manufacturer Narrative · 1

    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: ON INVESTIGATION, THE PUMP POWERED ON NORMALLY WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY FAILURE OF THE AUDITORY ALARM. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY DAMAGE, DEFECT OR CONTAMINATION OF THE INTERIOR PUMP COMPONENTS, INCLUDING THE AUDITORY ALARM ASSEMBLY UNIT. INVESTIGATION DID NOT DUPLICATE THE REPORTED ISSUE OF ¿NO SOUNDS¿ AND THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO SOUNDS) 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
    321517 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1