BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3171730 · Received June 16, 2013

    Report

    Report Number
    2531779-2013-08258
    Event Type
    Malfunction
    Date Received
    June 16, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/16/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/21/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY SHOWED THE LAST BASAL DELIVERY WAS ON 04/29/2013 WITH NO DELIVERY INTERRUPTIONS OR ANY ACTIVITY OUTSIDE OF NORMAL USE. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY INTERRUPTIONS OR ALARMS OCCURRING. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN REQUESTED BUT NOT RETURNED AT THE TIME OF THIS REPORT. WHEN THE DEVICE IS RETURNED IT WILL BE INVESTIGATED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DISTRIBUTOR REPORTED THAT THE PATIENT COMPLAINED ABOUT HYPERGLYCEMIA. IT WAS REPORTED THAT THE INFUSION SET WAS REPLACED SEVERAL TIMES WITHOUT RESOLUTION OF THE ISSUE. THE DISTRIBUTOR STATED THAT THE PUMP WAS REPLACED AND THE PATIENT REPORTED THAT THE HYPERGLYCEMIA RESOLVED EVEN WHEN THE SAME LOT NUMBER OF INFUSION SET WAS USED. THERE WAS NO REPORTED BLOOD GLUCOSE VALUES, NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA WERE NOTED, AND THERE WAS NO MENTION THAT MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH THIS DESCRIPTION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY, THERE IS AN IMPLICATION THAT THE PUMP MAY HAVE CAUSED OR CONTRIBUTED TO THE HYPERGLYCEMIC EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED UNSPECIFIED ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272742 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1