BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS VIBE

    MDR report key: 3023571 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03146
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) DEVICE EVALUATION: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED NO ACTIVITY OUTSIDE NORMAL USE. THE LAST BASAL DELIVERY RECORDED WAS ON (B)(6) 2013 AT 4:02 PM. THE TOTAL DAILY DOSE (TDD) CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATE. BLACK BOX RECORDS SHOWED THAT THE PUMP WAS TURNED ¿OFF¿ ON (B)(6) 2013 AT 11:28 AM AND THEN TURNED BACK ¿ON¿ ON (B)(6) 2013 AT 4:27 PM. ON INVESTIGATION, THE PUMP POWERED ON NORMALLY AND PRIMED SUCCESSFULLY. THE PUMP WAS EXERCISED FOR (B)(4) WITHOUT ALARMS OR DELIVERY INTERRUPTION. THE PUMP WAS FOUND TO BE DELIVERING INSULIN AS INTENDED. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF MOISTURE, DAMAGE OR DEFECT OF THE INTERIOR COMPONENTS OF THE PUMP. INVESTIGATION DID NOT REVEAL ANY DELIVERY ISSUE WITH THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS AND REPORTED AN UNDER DELIVERY ISSUE WITH THE PUMP. THE PATIENT REPORTEDLY EXPERIENCED ISSUES WITH HIGH BLOOD GLUCOSE (BG). THERE WAS NO REPORTED ADVERSE EVENT; NO REPORTED BG VALUES WERE PROVIDED. IT WAS NOTED THAT THE PUMP WAS TROUBLESHOOTED AND NO ISSUES WERE NOTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THERE WAS A DELIVERY ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126198 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1