BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3053466 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04079
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 13, 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 (B)(4) 2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED MULTIPLE OCCLUSION ALARMS LEADING TO DELIVERY INTERRUPTIONS. THE PUMP POWERED ON APPROPRIATELY TO THE VERIFY SCREEN, AND PASSED EZPRIME STEPS SUCCESSFULLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE RESISTANCE MEASUREMENT WAS FOUND TO BE WITHIN SPECIFICATION. AN OCCLUSION ALARM WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERTS. THE PUMP WAS OPENED AND INSPECTED, AND THERE WAS NO DEFECT FOUND WITH THE FORCE SENSOR CIRCUIT OR THE PCB.

    Additional Manufacturer Narrative · 1

    APPROPRIATELY EMITTED ALARMS ARE NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP IS ALARMING TO ALERT THE USER OF AN ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. 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. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013 THE PATIENT HAD GONE TO THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE (BG) OF 30 MMOL/L. THERE WERE NO REPORTED SIGNS OR SYMPTOM OF HYPERGLYCEMIA. THE DISTRIBUTOR REPORTED THE FOLLOWING SEQUENCE OF EVENTS LEADING UP TO THE REPORTED INCIDENT. THE PATIENT REPORTEDLY RECEIVED OCCLUSION ALARMS ON (B)(6) 2013 AS WELL AS A CS 012 ALARM ON (B)(6) 2013. THE PATIENT'S INFUSION SET INSERTION TECHNIQUE WAS REVIEWED, AND THE PATIENT WAS ADVISED ON HOW TO PROPERLY INSERT THE INFUSION SET. THE PATIENT'S BG REPORTEDLY REMAINED ELEVATED ON (B)(6) 2013 AFTER CHANGING THE INFUSION SET WITH CORRECTED TECHNIQUE, AND THE PATIENT REPORTEDLY ADMINISTERED 40 UNITS OF INSULIN WITH AN INSULIN PEN, AND THEN WENT TO THE HOSPITAL. THE DISTRIBUTOR NOTED THAT THE DIABETES NURSE EDUCATOR AT THE HOSPITAL FELT THAT THE PUMP WAS MALFUNCTIONING. THE PATIENT WAS REPORTEDLY GIVEN A BACK-UP PLAN OF INSULIN INJECTIONS AND WAS SENT HOME. THE PATIENT'S BGS WERE REPORTEDLY WITHIN NORMAL RANGE ON (B)(6) 2013, AND THE PATIENT WAS TO REMAIN ON INJECTIONS UNTIL A NEW PUMP WAS RECEIVED. THE PUMP WAS REPLACED DUE TO FREQUENT OCCLUSIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION OF A NON-SPECIFIC PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154569 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention