BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 3042360 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03836
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY INDICATED THE PUMP WAS USED FOR BASAL DELIVERY FOR 4 HOURS; NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED. THE PUMP POWERED ON AND DISPLAYED THE ¿VERIFY¿ SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS WITH NO DELIVERY INTERRUPTIONS OR ALARMS NOTED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP¿S COVER WAS REMOVED; NO INTERMITTENT ISSUES WERE FOUND TO THE POWER CIRCUIT. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING ON (B)(6) 2013 AT 1AM, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 2.0MMOL/L TO 2.7MMOL/L WITH SWEATINESS AND SHAKINESS. IT WAS NOTED THAT THE PATIENT WAS PREGNANT. THE PATIENT REPORTEDLY DISCONNECTED FROM THE PUMP, THE PATIENT HAD CORRECTED THE LOW WITH TAKING ORAL CARBOHYDRATES AND THE PATIENT'S BG WAS REPORTED TO 10MMOL/L THE NEXT MORNING. THE PATIENT STATED THAT THE PUMP WAS LOCKED AND SAID THAT A BOLUS WAS DELIVERED FROM THE PUMP THAT SHE DID NOT DELIVER. IT WAS NOTED THAT THE PATIENT WAS WONDERING IF THERE WAS AN ISSUE WITH THE AUDIO BOLUS BUTTON. THE PATIENT DENIED ISSUES WITH THE KEYPAD. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND NOTED NO ISSUES WITH THE AUDIO BOLUS BUTTON. CS ALSO REVIEWED THE PUMP HISTORY AND NO DELIVERY ISSUES WERE NOTED WITH THE PUMP BUT DURING THE REPORTED BG EVENT, THE DATE WAS REPORTED TO BE OFF BY ONE DAY. IT WAS NOTED THAT CS HAD THE PATIENT CORRECT THE DATE WITH NO ISSUES DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THAT A BOLUS WAS DELIVERED THE PATIENT CLAIMED SHE DID NOT DELIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144969 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening