BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3091921 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05837
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. COMPLAINT REGARDING IOB COULD NOT BE DUPLICATED. WHEN REVIEWING THE PUMP BASAL HISTORY FOR (B)(6) 2013, IT WAS NOTED THE BASAL SEGMENTS WERE RECORDED OUT OF TIME SEQUENCE THE BLACK BOX FOR (B)(6) 2013 WAS NO LONGER AVAILABLE DUE TO THE USER OVERRIDING THE DATA. USING THE PATIENTS BASAL SETTINGS AND IOB SETTINGS A 14.1 UNIT BOLUS WAS PROGRAMMED AND DELIVERED .IOB AFTER BOLUS REGISTERED 14.1 UNITS AND DEPLETED TO 1.0 UNIT AFTER 2.5 HOURS. IOB AFTER 3.5 HOURS REGISTERED 0 UNITS. IT HAS BEEN DETERMINED BASED ON THE BASAL HISTORY THE PUMP TIME WAS MANIPULATED OR INCORRECTLY CHANGED DURING THE IOB ANOMALY THE USER EXPERIENCED. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS TO CORRECT THE BRAND NAME FOR THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE INSULIN ON BOARD (IOB) FEATURE WAS NOT FUNCTIONING PROPERLY AND RESULTED IN LOW BLOOD GLUCOSE (BG). IT WAS REPORTED THAT EARLY IN THE MORNING ON (B)(6) 2013 THE PATIENT HAD A BG OF 3/1MMOL/L. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPOGLYCEMIA. THE DISTRIBUTOR REPORTED THAT THE PATIENT'S IOB WAS SET TO 3 HOURS, HOWEVER ON (B)(6) 2013 3.5 HOURS AFTER A BOLUS, THERE WAS STILL INSULIN ON BOARD SHOWING UP. THE REPORTED BG EXCURSION DOES NOT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED IOB ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193704 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1