BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3170232 · Received June 14, 2013

    Report

    Report Number
    2531779-2013-08238
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION (B)(6) 2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6)2015 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2013 AT 9:20AM. THE DATA FROM THE TIME OF THE ALLEGED INCIDENT WAS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THE PUMP WAS RETURNED WITH IOB DURATION SET TO 2 HOURS. A REVIEW OF THE BOLUS HISTORY SHOWED AN IOB READING OF 15UNITS AFTER TWO BOLUSES FOUR HOURS APART ON (B)(6) 2013 AT 7:50AM AND 11:51AM; A ¿STUCK¿ IOB WAS CONFIRMED IN THE PUMP HISTORY. THE PUMP POWERED ON NORMALLY AND SUCCESSFULLY COMPLETED EZPRIME STEPS. A 10UNIT BOLUS WAS PERFORMED WITH A DURATION OF TWO HOURS; AFTER THE TWO HOUR PERIOD THE IOB WAS SHOWING 0UNITS. THE ALLEGED IOB ISSUE WAS CONFIRMED IN THE PUMP HISTORY BUT COULD NOT BE DUPLICATED ON INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PATIENT CORRECTED AN ELEVATED BLOOD GLUCOSE (BG) OF 30.1MMOL/L USING THE PUMP RECOMMENDATIONS WHICH INCLUDED THE INSULIN ON BOARD (IOB), AND EXPERIENCED A LOW BG OF 3.9MMOL/L AFTER THE RECOMMENDED CORRECTION. THE PATIENT WAS REPORTEDLY ABLE TO SELF-TREAT THE LOW BG WITH ORAL CARBOHYDRATES AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT REPORTEDLY ALLEGED THAT THE IOB IS NOT CALCULATING PROPERLY. IT WAS REPORTED THAT THE PATIENT HAS THE IOB DURATION SET FOR TWO HOURS, AND THE IOB HAD LISTED 14 UNITS AT THE TIME THE PATIENT WENT TO CORRECT THE ELEVATED BG, HOWEVER THE LAST BOLUS HAD REPORTEDLY OCCURRED OVER THREE HOURS PRIOR. THE PATIENT REPORTEDLY HAD ONLY BOLUSED 7 UNITS FOR THAT DAY PRIOR TO THE CORRECTION; HOWEVER THE IOB LISTED 14 UNITS. THE PATIENT¿S TARGET BG IS REPORTEDLY 5.5MMOL/L AND THE INSULIN SENSITIVITY FACTOR WAS REPORTED TO BE 1.8. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION OF THE IOB NOT FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270720 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1