BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3223681 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10508
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE EXISTENCE OF A REPORTABLE ADVERSE EVENT RELATED TO THE ALLEGED ELEVATED BG. AS A RESULT, NO ADVERSE EVENT IS BEING REPORTED ASSOCIATED WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(6) .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.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE BLACK BOX DATA REVEALED RECORDS FROM (B)(6) 2013. THE LAST BASAL DELIVERY WAS RECORDED ON (B)(6) 2013, WHICH WAS FOLLOWED BY A "LOSS OF PRIME" WARNING AND DELIVERIES WERE NOT RESUMED. THERE WERE NO "POWER ON RESET" EVENTS OR DELIVERY INTERRUPTIONS OBSERVED IN THE DATA. THE BATTERY VOLTAGE WAS NOTED TO BE ABOVE THE "LOW BATTERY" AND "REPLACE BATTERY" WARNING THRESHOLDS PRIOR TO THE "LOSS OF PRIME" EVENT. ON EXAMINATION, THE PUMP WAS INTACT WITHOUT DAMAGE OR MOISTURE INGRESS TO THE BATTERY COMPARTMENT. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION FIT SECURELY ON THE PUMP AND WAS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION. ON TESTING, THE PUMP POWERED ON NORMALLY WITH FULLY FUNCTIONAL AUDITORY AND VIBRATORY ALERTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER INTERRUPTION. A "LOW BATTERY" WARNING AND "REPLACE BATTERY" ALARM WAS INDUCED AND THE PUMP RESPONDED APPROPRIATELY WITH THE CORRECT VISIBLE AND AUDIBLE ALERT. THE PUMP WAS OPENED FOR INVESTIGATION WITH NO EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION PRESENT INSIDE THE PUMP OR AFFECTING THE POWER CIRCUIT. INVESTIGATION WAS UNABLE TO CONFIRM OR DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR ALLEGED ON (B)(6) 2013 THE PUMP POWERED OFF WITHOUT PRIOR WARNING DURING THE NIGHT DUE TO A DRAINED BATTERY. THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA. THE DISTRIBUTOR ALLEGED THERE WAS NO RECORD IN THE PUMP¿S ALARM HISTORY OF ¿LOW BATTERY¿ OR ¿REPLACE BATTERY¿ PRIOR TO THE PUMP LOSING POWER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED LOSS OF POWER WITHOUT PRIOR WARNING REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323646 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1